Biomedical Engineer Jobs - Doha Qatar
18 Jobs Found
<p>Position Summary</p><p> </p><p>We are looking for a proactive, organized, and detail-oriented Junior Healthcare Administrative Assistant to support our administrative, quotation, procurement, and tendering activities and contribute to the smooth daily operation of our office.</p><p> </p><p>This position is suitable for fresh graduates or candidates with up to 2 years of experience who are interested in developing a career in the healthcare supply and medical procurement sector.</p><p> </p><p>Key Responsibilities</p><p> </p><p>* Assist in preparing quotations and tender documentation.</p><p>* Assist with RFQs and supplier communications.</p><p>* Maintain organized records and filing systems.</p><p>* Coordinate with suppliers and customers.</p><p>* Support procurement and administrative activities.</p><p>* Prepare reports and follow up on daily office tasks.</p><p>* Assist with purchase orders, delivery documents, and related records.</p><p>* Support the Senior Administrative & Tendering Officer and management team as required.</p><p> </p><p>Requirements</p><p> </p><p>* Fresh graduates or candidates with up to 2 years of experience.</p><p>* Degree/diploma in Biomedical Engineering, Medical Sciences, Healthcare, Supply Chain, Business Administration, or a related field is preferred.</p><p>* Previous experience in a medical or healthcare supply company is an advantage.</p><p>* Good English communication and writing skills.</p><p>* Proficiency in Microsoft Office, particularly Word and Excel.</p><p>* Strong organizational skills and attention to detail.</p><p>* Positive attitude, willingness to learn, and ability to develop professionally.</p><p>* Ability to work as part of a team and meet deadlines.</p><p> </p><p>Salary & Benefits</p><p> </p><p>* Starting salary: QAR 3,000–4,000, depending on qualifications and experience.</p><p>* Annual salary review.</p><p>* Performance-based bonus.</p><p>* 30 calendar days annual leave.</p><p>* Return air ticket every two years.</p><p>* Excellent opportunities for career growth and professional development.</p><p> </p><p>Why Join RQM?</p><p> </p><p>* Join a growing and specialized healthcare company in Qatar.</p><p>* Develop your career within the healthcare supply and medical procurement sector.</p><p>* Work alongside experienced professionals and international suppliers.</p><p>* Gain practical experience in tendering, procurement, medical equipment spare parts, and medical consumables.</p><p>* Be part of a company with long-term growth and expansion plans.</p><p> </p><p>⸻</p><p> </p><p> </p><p>Example:</p><p>Application – Senior Healthcare Administrative & Tendering Officer</p><p> </p><p>or</p><p> </p><p>Application – Junior Healthcare Administrative Assistant</p><p> </p><p>Only shortlisted candidates will be contacted.</p>
<ul><li><p>Install, inspect, calibrate, maintain, and repair biomedical and medical equipment.</p></li><li><p>Perform preventive and corrective maintenance on medical devices.</p></li><li><p>Troubleshoot equipment failures and coordinate repairs with manufacturers or service providers.</p></li><li><p>Conduct safety and performance testing of medical equipment.</p></li><li><p>Ensure equipment complies with applicable safety standards, regulations, and hospital policies.</p></li><li><p>Investigate equipment incidents and recommend corrective or preventive actions.</p></li><li><p>Work with clinical and technical teams to identify equipment and technology requirements.</p></li><li><p>Assist with risk assessments, audits, and quality-improvement activities.</p></li><li><p>Stay current with developments in medical devices, healthcare technology, and relevant regulations.</p></li></ul><p><br></p><p><strong>Qualifications:</strong><br></p><ul><li><p>Bachelor's degree in Biomedical Engineering.</p></li><li><p>Minimum 3–5 years of experience in the Qatari market.</p></li><li><p>Strong Knowledge of medical equipment, electronics, instrumentation, and basic mechanical systems.</p></li><li><p>Willingness to travel extensively within Qatar for customer visits and business development activities.</p></li><li><p>Understanding of medical-device safety standards and maintenance procedures.</p></li><li><p>Strong troubleshooting and analytical skills.</p></li><li><p>Participate in exhibitions, conferences, seminars, and other promotional activities to increase brand awareness.</p></li><li><p>Ability to work effectively with doctors, nurses, technicians, suppliers, and other departments.</p></li></ul><p><strong>Desired Candidate Profile</strong></p><p>Relevant professional certifications or training from medical-device manufacturers is an advantage.</p>
<section><p class="heading jdMain">Job Description</p><p class="heading">Roles & Responsibilities</p><div class="paragraph"><p><b>Biomedical / Pharma Background</b></p><p><br></p><ul style="font-size: 11px;"><li style="font-size: 11px;">3-5 years Experience in Qatar</li><li style="font-size: 11px;">Experience in Emergency/ Sports Medicine/ CSSD/ Radiology is preferable.</li><li style="font-size: 11px;">Driving License is must.</li></ul></div></section><section><p class="heading">Desired Candidate Profile</p><p class="paragraph"></p><ul><li><br></li></ul><p></p></section>
<p></p><ul><li><p>Promote Promoitalia’s professional aesthetic portfolio to dermatologists and aesthetic clinics.</p></li><li><p>Build and maintain strong relationships with healthcare professionals.</p></li><li><p>Conduct regular clinic visits and achieve sales targets.</p></li><li><p>Provide product knowledge, presentations, and clinical support to doctors.</p></li><li><p>Identify new business opportunities and expand the customer base.</p></li><li><p>Monitor market trends and competitor activities.</p></li><li><p>Prepare sales reports and maintain customer records.</p></li></ul><p><strong>Desired Candidate Profile</strong></p><ul><li><p>2–3 years of experience as a Medical Representative, preferably in dermatology/aesthetic field.</p></li><li><p>Bachelor’s degree in Pharmacy, Nursing, Biomedical Science, or related field.</p></li><li><p>Strong communication, presentation, and negotiation skills.</p></li><li><p>Results-driven with a passion for sales and building doctor relationships.</p></li><li><p>Good knowledge of aesthetic products and procedures is preferred.</p></li><li><p>Fluent in English with valid Qatar ID and driving license.</p></li></ul>
<section><p class="heading jdMain">Job Description</p><p class="heading">Roles & Responsibilities</p><div class="paragraph"><p>The Department of Biological Sciences at Carnegie Mellon University in Qatar (CMU-Q) is seeking a highly motivated Research Associate to support the research program spanning the laboratories.</p><p>Responsibilities :</p><p>Younis Lab :</p><ul><li>Conducting experiments on the role of minor intron splicing in breast cancer.</li><li>Setup and optimize new techniques, including but not limited to immuno- fluorescence and colony formation assay.</li><li>Required experiments and techniques are in the areas of Molecular Biology, Genetics, Genomics and Biochemistry.</li><li>Data analysis.</li><li>Supervise other researchers in the lab.</li><li>Assist in writing reports and manuscripts.</li><li>Setup next generation sequencing experiments (RNA-Seq).</li><li>Analyze and confirm RNA-seq results.</li></ul><p>Naik lab :</p><ul><li>Working on several aspects of the project titled "Investigating PARP inhibition in colorectal cancer cell lines and combinatorial approaches to improve sensitivity". The successful candidate will contribute to laboratory-based research involving mammalian cell culture, molecular biology techniques, functional assays, data analysis, and laboratory management.</li><li>Responsibilities will also include mentoring undergraduate researchers, maintaining laboratory records, writing manuscripts and supporting collaborative research projects.</li></ul><p>Joining the CMU team opens the door to an array of exceptional benefits. Benefits eligible employees enjoy a wide array of benefits including comprehensive medical, prescription, dental, and vision insurance as well as a generous retirement savings program with employer contributions. Unlock your potential with tuition benefits, take well-deserved breaks with ample paid time off and observed holidays, and rest easy with life and accidental death and disability insurance. Additional perks include a free Pittsburgh Regional Transit bus pass, access to our Family Concierge Team to help navigate childcare needs, fitness center access, and much more!</p><p>For a comprehensive overview of the benefits available, explore our Benefits page.</p><p>At Carnegie Mellon, we value the whole package when extending offers of employment. Beyond credentials, we evaluate the role and responsibilities, your valuable work experience, and the knowledge gained through education and training. We appreciate your unique skills and the perspective you bring. Your journey with us is about more than just a job; it s about finding the perfect fit for your professional growth and personal aspirations.</p><p>Are you interested in an exciting opportunity with an exceptional organization?! Apply today!</p><p>Location Doha, Qatar</p><p>Job Function Researchers</p><p>Position Type Staff Fixed Term (Fixed Term)</p><p>Full Time/Part time Full time</p><p>Pay Basis Hourly</p></div></section><section><p class="heading">Desired Candidate Profile</p><p class="paragraph"></p><p>Candidates should hold a Master s degree in Biological Sciences, Biomedical Sciences, Molecular Biology, or a related field. Prior experience with cell culture, cancer biology, and laboratory research is required Strong organizational, communication, and teamwork skills are essential.</p><p></p></section>
The Department of Biological Sciences at Carnegie Mellon University in Qatar (CMU-Q) is seeking a highly motivated Research Associate to support the research program spanning the laboratories.<br><br>Responsibilities:<br><br>Younis Lab:<br><br>1-Conducting experiments on the role of minor intron splicing in breast cancer. 2- Setup and optimize new techniques, including but not limited to immuno-<br><br>fluorescence and colony formation assay.<br><br>3-Required experiments and techniques are in the areas of Molecular Biology, Genetics, Genomics and Biochemistry.<br><br>4-Data analysis.<br><br>5-Supervise other researchers in the lab.<br><br>6-Assist in writing reports and manuscripts.<br><br>7-Setup next generation sequencing experiments (RNA-Seq).<br><br>8-Analyze and confirm RNA-seq results.<br><br>Naik lab:<br><br>1-Working on several aspects of the project titled "Investigating PARP inhibition in colorectal cancer cell lines and combinatorial approaches to improve sensitivity".<br><br>The successful candidate will contribute to laboratory-based research involving mammalian cell culture, molecular biology techniques, functional assays, data<br><br>analysis, and laboratory management.<br><br>Responsibilities will also include mentoring undergraduate researchers, maintaining laboratory records, writing manuscripts and supporting collaborative research projects.<br><br>Candidates should hold a Master’s degree in Biological Sciences, Biomedical Sciences, Molecular Biology, or a related field. <br><br>Prior experience with cell culture, cancer biology, and laboratory research is required Strong organizational, communication, and teamwork skills are essential.<br><br>Joining the CMU team opens the door to an array of exceptional benefits.<br><br>Benefits eligible employees enjoy a wide array of benefits including comprehensive medical, prescription, dental, and vision insurance as well as a generous retirement savings program with employer contributions. Unlock your potential with tuition benefits, take well-deserved breaks with ample paid time off and observed holidays, and rest easy with life and accidental death and disability insurance. <br><br>Additional perks include a free Pittsburgh Regional Transit bus pass, access to our Family Concierge Team to help navigate childcare needs, fitness center access, and much more!<br><br>For a comprehensive overview of the benefits available, explore our Benefits page.<br><br>At Carnegie Mellon, we value the whole package when extending offers of employment. Beyond credentials, we evaluate the role and responsibilities, your valuable work experience, and the knowledge gained through education and training. We appreciate your unique skills and the perspective you bring. Your journey with us is about more than just a job; it’s about finding the perfect fit for your professional growth and personal aspirations.<br><br>Are you interested in an exciting opportunity with an exceptional organization?! Apply today!<br><br>Location<br><br>Doha, Qatar<br><br>Job Function<br><br>Researchers<br><br>Position Type<br><br>Staff – Fixed Term (Fixed Term)<br><br>Full Time/Part time<br><br>Full time<br><br>Pay Basis<br><br>Hourly<br><br>More Information: <br><br>Please visit “Why Carnegie Mellon” to learn more about becoming part of an institution inspiring innovations that change the world. Click here to view a listing of employee benefits Carnegie Mellon University is an Equal Opportunity Employer/Disability/Veteran. Statement of Assurance
The Department of Biological Sciences at Carnegie Mellon University in Qatar (CMU-Q) is seeking a highly motivated Research Associate to support the research program spanning the laboratories.<br><br>Responsibilities:<br><br>Younis Lab:<br><br>1-Conducting experiments on the role of minor intron splicing in breast cancer. 2- Setup and optimize new techniques, including but not limited to immuno-<br><br>fluorescence and colony formation assay.<br><br>3-Required experiments and techniques are in the areas of Molecular Biology, Genetics, Genomics and Biochemistry.<br><br>4-Data analysis.<br><br>5-Supervise other researchers in the lab.<br><br>6-Assist in writing reports and manuscripts.<br><br>7-Setup next generation sequencing experiments (RNA-Seq).<br><br>8-Analyze and confirm RNA-seq results.<br><br>Naik lab:<br><br>1-Working on several aspects of the project titled "Investigating PARP inhibition in colorectal cancer cell lines and combinatorial approaches to improve sensitivity".<br><br>The successful candidate will contribute to laboratory-based research involving mammalian cell culture, molecular biology techniques, functional assays, data<br><br>analysis, and laboratory management.<br><br>Responsibilities will also include mentoring undergraduate researchers, maintaining laboratory records, writing manuscripts and supporting collaborative research projects.<br><br>Candidates should hold a Master’s degree in Biological Sciences, Biomedical Sciences, Molecular Biology, or a related field. <br><br>Prior experience with cell culture, cancer biology, and laboratory research is required Strong organizational, communication, and teamwork skills are essential.<br><br>Joining the CMU team opens the door to an array of exceptional benefits.<br><br>Benefits eligible employees enjoy a wide array of benefits including comprehensive medical, prescription, dental, and vision insurance as well as a generous retirement savings program with employer contributions. Unlock your potential with tuition benefits, take well-deserved breaks with ample paid time off and observed holidays, and rest easy with life and accidental death and disability insurance. <br><br>Additional perks include a free Pittsburgh Regional Transit bus pass, access to our Family Concierge Team to help navigate childcare needs, fitness center access, and much more!<br><br>For a comprehensive overview of the benefits available, explore our Benefits page.<br><br>At Carnegie Mellon, we value the whole package when extending offers of employment. Beyond credentials, we evaluate the role and responsibilities, your valuable work experience, and the knowledge gained through education and training. We appreciate your unique skills and the perspective you bring. Your journey with us is about more than just a job; it’s about finding the perfect fit for your professional growth and personal aspirations.<br><br>Are you interested in an exciting opportunity with an exceptional organization?! Apply today!<br><br>Location<br><br>Doha, Qatar<br><br>Job Function<br><br>Researchers<br><br>Position Type<br><br>Staff – Fixed Term (Fixed Term)<br><br>Full Time/Part time<br><br>Full time<br><br>Pay Basis<br><br>Hourly<br><br>More Information: <br><br>Please visit “Why Carnegie Mellon” to learn more about becoming part of an institution inspiring innovations that change the world. Click here to view a listing of employee benefits Carnegie Mellon University is an Equal Opportunity Employer/Disability/Veteran. Statement of Assurance
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing Nav IQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar.<br><br>About Shifamed<br><br>Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.<br><br>Description:<br><br>Akura Medical, a Shifamed portfolio company, is seeking a highly skilled and motivated Sr. or Staff Software Engineer to contribute to the design, development, and integration of advanced medical imaging systems. In this role, you will serve as a senior technical contributor, applying your expertise to solve complex engineering problems while collaborating across multidisciplinary teams. You will play a critical role in developing innovative imaging technologies that meet regulatory standards and advance patient care. This is a full-time, on-site position at our new, R&D facility in Doha, Qatar.<br><br>Responsibilities, Skills & Hands-On Experience:<br><br>Contribute to the architecture, design, and integration of medical image processing systems, ensuring scalability, reliability, and compliance with regulatory requirements (e.g., FDA, ISO 13485). Develop and implement imaging algorithms, visualization tools, and system components. Collaborate closely with R&D, clinical, regulatory, and manufacturing teams to align technical deliverables with program objectives. Perform feasibility studies, risk assessments, and trade-off analyses to guide design decisions. Mentor junior engineers, sharing best practices in design, coding, and testing. Partner with external vendors and collaborators to support imaging-related initiatives. Develop and execute testing protocols, verification, and validation processes. Contribute to technical documentation, including regulatory submissions. Stay current with industry trends and emerging technologies in medical imaging, proposing improvements and new approaches.<br><br><br>Education & Work Experience:<br><br>Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Computer Science, or related field (M. S. preferred).8+ years of experience in medical imaging systems design and development. Strong knowledge of imaging modalities (e.g., X-ray, MRI, ultrasound) and image processing algorithms. Proficiency in software development (e.g., MATLAB, Python, C++), visualization, and hardware integration. Experience with UI frameworks such as VTK and Qt/QML. Experience with cloud-based imaging applications and integration of AI/ML methods for computer vision/medical imaging. Solid understanding of regulatory and quality standards, including cybersecurity (e.g., ISO 13485, IEC 60601, FDA requirements). Track record of technical contributions, including patents, publications, or conference presentations in medical imaging. Strong problem-solving, communication, and collaboration skills. Ability to succeed in a fast-paced, entrepreneurial environment.<br><br><br>Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.<br><br>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing Nav IQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar.<br><br>About Shifamed<br><br>Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.<br><br>Description:<br><br>Akura Medical, a Shifamed portfolio company, is seeking a highly skilled and motivated Sr. or Staff Software Engineer to contribute to the design, development, and integration of advanced medical imaging systems. In this role, you will serve as a senior technical contributor, applying your expertise to solve complex engineering problems while collaborating across multidisciplinary teams. You will play a critical role in developing innovative imaging technologies that meet regulatory standards and advance patient care. This is a full-time, on-site position at our new, R&D facility in Doha, Qatar.<br><br>Responsibilities, Skills & Hands-On Experience:<br><br>Contribute to the architecture, design, and integration of medical image processing systems, ensuring scalability, reliability, and compliance with regulatory requirements (e.g., FDA, ISO 13485). Develop and implement imaging algorithms, visualization tools, and system components. Collaborate closely with R&D, clinical, regulatory, and manufacturing teams to align technical deliverables with program objectives. Perform feasibility studies, risk assessments, and trade-off analyses to guide design decisions. Mentor junior engineers, sharing best practices in design, coding, and testing. Partner with external vendors and collaborators to support imaging-related initiatives. Develop and execute testing protocols, verification, and validation processes. Contribute to technical documentation, including regulatory submissions. Stay current with industry trends and emerging technologies in medical imaging, proposing improvements and new approaches.<br><br><br>Education & Work Experience:<br><br>Bachelor’s degree in Electrical Engineering, Biomedical Engineering, Computer Science, or related field (M. S. preferred).8+ years of experience in medical imaging systems design and development. Strong knowledge of imaging modalities (e.g., X-ray, MRI, ultrasound) and image processing algorithms. Proficiency in software development (e.g., MATLAB, Python, C++), visualization, and hardware integration. Experience with UI frameworks such as VTK and Qt/QML. Experience with cloud-based imaging applications and integration of AI/ML methods for computer vision/medical imaging. Solid understanding of regulatory and quality standards, including cybersecurity (e.g., ISO 13485, IEC 60601, FDA requirements). Track record of technical contributions, including patents, publications, or conference presentations in medical imaging. Strong problem-solving, communication, and collaboration skills. Ability to succeed in a fast-paced, entrepreneurial environment.<br><br><br>Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.<br><br>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing Nav IQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar. To learn more about Akura Medical, please visit www.akuramed.com.<br>About Shifamed Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.<br>Description:<br>This position represents an exciting opportunity to join the Akura team at an early stage where you will creatively design and develop components, both consumable and capital equipment, of a blood clot removal system. The role focuses on mechanical design of various components and assemblies for catheter systems, a console, and cross-functional leadership from concept through high volume manufacturing. You will be responsible for the design, vendor relationships and testing per applicable standards. This is a full-time, on-site position at our Doha, Qatar office.<br>Responsibilities, Skills & Hands-On Experience:Lead design and development of plastic/composite and metallic parts from concept to high volume manufacturing; drive DFM/DFS, manufacturing and tooling decisions with suppliers. Drive the full mechanical lifecycle: requirements, concepts, prototyping, detailed design, V&V, and transition to production. Integrate mechanical designs with electronics, firmware, fluid, and user-interface elements in collaboration with cross-functional teams. Guide analysis (tolerance stacks, FEA, material selection, root-cause) on critical subsystems. Creative solutions and product designs to satisfy unmet clinical needs in thrombectomy. Be a primary contributor to the intellectual property position of the company via invention disclosures and prototypes to demonstrate reduction to practice. Interact with physicians to assist with product demonstrations and product testing. Effectively document work throughout the development process though design reviews, manufacturing instructions, test methods, and test reports. Expertise in design and development of medical devices. Expertise in electromechanical and mechanism design of durable medical devices. Substantial experience in design of higher volume disposable components. Substantial experience in design for molding and machining. Substantial experience in design for manufacturing. Pilot production experience. Expertise in product, tool and fixture design using Solid Works. Performance test apparatus and test method development. Process development on both a prototype and manufacturing level. Mentoring and assisting team members with less experience. Participating in lab and cleanroom environment builds. Process optimization and design of experiment based on statistical methodology. Selecting and managing suppliers, including understanding of capabilities, materials, and fabrication processes Working independently and in a project team setting. Supporting regulatory filings including writing technical sections and providing general technical input.<br>Education & Work Experience:Bachelor's Degree or higher in Mechanical/Biomedical Engineering. At least 15 years of experience in complex product development, including regulated products. Advanced Solid Works proficiency. Demonstrated track record as a lead/principal engineer or product design of medical devices from concept through launch. Strong expertise in injection molding and RIM molding (part design, materials, DFM, cosmetic and structural considerations). Strong experience with medical devices under FDA/ISO 13485 or equivalent regulatory frameworks. Previous experience working with clinical testing, trials, data collection, and statistical analysis.<br>Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.<br>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing Nav IQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar. To learn more about Akura Medical, please visit www.akuramed.com.<br>About Shifamed Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.<br>Description:<br>This position represents an exciting opportunity to join the Akura team at an early stage where you will creatively design and develop components, both consumable and capital equipment, of a blood clot removal system. The role focuses on mechanical design of various components and assemblies for catheter systems, a console, and cross-functional leadership from concept through high volume manufacturing. You will be responsible for the design, vendor relationships and testing per applicable standards. This is a full-time, on-site position at our Doha, Qatar office.<br>Responsibilities, Skills & Hands-On Experience:Lead design and development of plastic/composite and metallic parts from concept to high volume manufacturing; drive DFM/DFS, manufacturing and tooling decisions with suppliers. Drive the full mechanical lifecycle: requirements, concepts, prototyping, detailed design, V&V, and transition to production. Integrate mechanical designs with electronics, firmware, fluid, and user-interface elements in collaboration with cross-functional teams. Guide analysis (tolerance stacks, FEA, material selection, root-cause) on critical subsystems. Creative solutions and product designs to satisfy unmet clinical needs in thrombectomy. Be a primary contributor to the intellectual property position of the company via invention disclosures and prototypes to demonstrate reduction to practice. Interact with physicians to assist with product demonstrations and product testing. Effectively document work throughout the development process though design reviews, manufacturing instructions, test methods, and test reports. Expertise in design and development of medical devices. Expertise in electromechanical and mechanism design of durable medical devices. Substantial experience in design of higher volume disposable components. Substantial experience in design for molding and machining. Substantial experience in design for manufacturing. Pilot production experience. Expertise in product, tool and fixture design using Solid Works. Performance test apparatus and test method development. Process development on both a prototype and manufacturing level. Mentoring and assisting team members with less experience. Participating in lab and cleanroom environment builds. Process optimization and design of experiment based on statistical methodology. Selecting and managing suppliers, including understanding of capabilities, materials, and fabrication processes Working independently and in a project team setting. Supporting regulatory filings including writing technical sections and providing general technical input.<br>Education & Work Experience:Bachelor's Degree or higher in Mechanical/Biomedical Engineering. At least 15 years of experience in complex product development, including regulated products. Advanced Solid Works proficiency. Demonstrated track record as a lead/principal engineer or product design of medical devices from concept through launch. Strong expertise in injection molding and RIM molding (part design, materials, DFM, cosmetic and structural considerations). Strong experience with medical devices under FDA/ISO 13485 or equivalent regulatory frameworks. Previous experience working with clinical testing, trials, data collection, and statistical analysis.<br>Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.<br>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing Nav IQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar. To learn more about Akura Medical, please visit www.akuramed.com.<br><br>About Shifamed<br><br>Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.<br><br>Description:<br><br>This position represents an exciting opportunity to join the Akura team at an early stage where you will creatively design and develop components, both consumable and capital equipment, of a blood clot removal system. The role focuses on mechanical design of various components and assemblies for catheter systems, a console, and cross-functional leadership from concept through high volume manufacturing. You will be responsible for the design, vendor relationships and testing per applicable standards. This is a full-time, on-site position at our Doha, Qatar office.<br><br>Responsibilities, Skills & Hands-On Experience:<br><br>Lead design and development of plastic/composite and metallic parts from concept to high volume manufacturing; drive DFM/DFS, manufacturing and tooling decisions with suppliers. Drive the full mechanical lifecycle: requirements, concepts, prototyping, detailed design, V&V, and transition to production. Integrate mechanical designs with electronics, firmware, fluid, and user-interface elements in collaboration with cross-functional teams. Guide analysis (tolerance stacks, FEA, material selection, root-cause) on critical subsystems. Creative solutions and product designs to satisfy unmet clinical needs in thrombectomy. Be a primary contributor to the intellectual property position of the company via invention disclosures and prototypes to demonstrate reduction to practice. Interact with physicians to assist with product demonstrations and product testing. Effectively document work throughout the development process though design reviews, manufacturing instructions, test methods, and test reports. Expertise in design and development of medical devices. Expertise in electromechanical and mechanism design of durable medical devices. Substantial experience in design of higher volume disposable components. Substantial experience in design for molding and machining. Substantial experience in design for manufacturing. Pilot production experience. Expertise in product, tool and fixture design using Solid Works. Performance test apparatus and test method development. Process development on both a prototype and manufacturing level. Mentoring and assisting team members with less experience. Participating in lab and cleanroom environment builds. Process optimization and design of experiment based on statistical methodology. Selecting and managing suppliers, including understanding of capabilities, materials, and fabrication processes Working independently and in a project team setting. Supporting regulatory filings including writing technical sections and providing general technical input.<br><br><br>Education & Work Experience:<br><br>Bachelor's Degree or higher in Mechanical/Biomedical Engineering. At least 15 years of experience in complex product development, including regulated products. Advanced Solid Works proficiency. Demonstrated track record as a lead/principal engineer or product design of medical devices from concept through launch. Strong expertise in injection molding and RIM molding (part design, materials, DFM, cosmetic and structural considerations). Strong experience with medical devices under FDA/ISO 13485 or equivalent regulatory frameworks. Previous experience working with clinical testing, trials, data collection, and statistical analysis.<br><br><br>Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.<br><br>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing Nav IQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar. To learn more about Akura Medical, please visit www.akuramed.com.<br><br>About Shifamed<br><br>Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.<br><br>Description:<br><br>This position represents an exciting opportunity to join the Akura team at an early stage where you will creatively design and develop components, both consumable and capital equipment, of a blood clot removal system. The role focuses on mechanical design of various components and assemblies for catheter systems, a console, and cross-functional leadership from concept through high volume manufacturing. You will be responsible for the design, vendor relationships and testing per applicable standards. This is a full-time, on-site position at our Doha, Qatar office.<br><br>Responsibilities, Skills & Hands-On Experience:<br><br>Lead design and development of plastic/composite and metallic parts from concept to high volume manufacturing; drive DFM/DFS, manufacturing and tooling decisions with suppliers. Drive the full mechanical lifecycle: requirements, concepts, prototyping, detailed design, V&V, and transition to production. Integrate mechanical designs with electronics, firmware, fluid, and user-interface elements in collaboration with cross-functional teams. Guide analysis (tolerance stacks, FEA, material selection, root-cause) on critical subsystems. Creative solutions and product designs to satisfy unmet clinical needs in thrombectomy. Be a primary contributor to the intellectual property position of the company via invention disclosures and prototypes to demonstrate reduction to practice. Interact with physicians to assist with product demonstrations and product testing. Effectively document work throughout the development process though design reviews, manufacturing instructions, test methods, and test reports. Expertise in design and development of medical devices. Expertise in electromechanical and mechanism design of durable medical devices. Substantial experience in design of higher volume disposable components. Substantial experience in design for molding and machining. Substantial experience in design for manufacturing. Pilot production experience. Expertise in product, tool and fixture design using Solid Works. Performance test apparatus and test method development. Process development on both a prototype and manufacturing level. Mentoring and assisting team members with less experience. Participating in lab and cleanroom environment builds. Process optimization and design of experiment based on statistical methodology. Selecting and managing suppliers, including understanding of capabilities, materials, and fabrication processes Working independently and in a project team setting. Supporting regulatory filings including writing technical sections and providing general technical input.<br><br><br>Education & Work Experience:<br><br>Bachelor's Degree or higher in Mechanical/Biomedical Engineering. At least 15 years of experience in complex product development, including regulated products. Advanced Solid Works proficiency. Demonstrated track record as a lead/principal engineer or product design of medical devices from concept through launch. Strong expertise in injection molding and RIM molding (part design, materials, DFM, cosmetic and structural considerations). Strong experience with medical devices under FDA/ISO 13485 or equivalent regulatory frameworks. Previous experience working with clinical testing, trials, data collection, and statistical analysis.<br><br><br>Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.<br><br>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing Nav IQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar.<br>ABOUT SHIFAMEDFounded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.<br>Description:<br>This Manager / Sr. Manager, Regulatory Affairs will serve as a key member of the cross-functional team, partnering closely with Clinical, Quality, R&D, and Executive Leadership to support U. S. regulatory activities and lead global clinical studies and international market expansion. The ideal candidate brings strong FDA medical device experience combined with hands-on knowledge of international regulatory pathways, agency interactions, and clinical study support across Europe, the Middle East, and other global markets. This is a unique opportunity to help shape regulatory strategy for a clinical-stage medical device company as it expands global clinical activities, and prepares for international commercialization.<br>Responsibilities, Skills & Hands-On Experience:<br>Regulatory Strategy & Product Development:Develop and execute global regulatory strategies for Akura Medical's thrombectomy and catheter-based cardiovascular technologies. Serve as regulatory lead on cross-functional product development teams from concept through commercialization. Provide regulatory guidance on design controls, risk management, verification and validation activities, labeling, and product changes. Partner with Quality and R&D teams to ensure compliance with FDA, MDR, ISO 13485, and applicable international requirements. FDA Regulatory Affairs Lead preparation, review, and submission of U. S. regulatory filings, including IDE's, 510(k)'s, supplements, and other regulatory submissions as applicable. Monitor evolving FDA requirements and assess impact on development and commercialization plans. International Regulatory Expansion Develop regulatory strategies and market access plans for Europe, the Middle East, and other international markets. Support CE Mark and MDR-related activities in partnership with Notified Bodies and external regulatory consultants. Lead country-specific registration activities and regulatory submissions across key international markets including Qatar, UAE, Saudi Arabia, and other MENA countries. Establish and maintain relationships with regulatory authorities, notified bodies, and international regulatory partners. Clinical & Regulatory Operations Partner closely with Clinical Affairs to support global clinical studies, including IDE, PMCF, registries, and post-market studies. Provide regulatory guidance on protocol development, clinical study design, and regulatory approval pathways. Support regulatory submissions associated with clinical trial approvals across multiple countries and regions. Participate in investigator meetings, regulatory inspections, audits, and agency interactions. Agency Interactions & Compliance Represent the company during interactions with FDA, Notified Bodies, Ministries of Health, and other regulatory authorities. Support preparation for regulatory inspections and audits. Maintain awareness of evolving global regulatory requirements and communicate potential impacts to leadership. Contribute to regulatory intelligence activities and long-term market expansion planning. Cross-Functional Leadership Collaborate with Clinical, Quality, Manufacturing, Supply Chain, and R&D teams to ensure regulatory requirements are incorporated throughout the product lifecycle. Provide regulatory leadership for change assessments, design modifications, and lifecycle management activities. Support Executive Leadership with regulatory risk assessments, timelines, and strategic planning.<br>Qualifications & Experience:Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or related field.10+ years of Regulatory Affairs experience within the medical device industry; cardiovascular, endovascular, or interventional products strongly preferred. Direct experience with FDA medical device submissions, including IDE's, PMA's, 510(k)'s, or PMA supplements. Experience supporting clinical-stage medical device programs and global clinical studies. Working knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304, and international regulatory frameworks. Experience interacting directly with regulatory agencies, notified bodies, and international health authorities. Familiarity with MENA regulatory pathways (Saudi SFDA, UAE MOHAP/DOH, Qatar MOPH, etc.) is highly desirable. Strong understanding of design controls, risk management, clinical evidence requirements, and regulatory strategy development. Excellent written, verbal, and presentation skills. Ability to thrive in a fast-paced, entrepreneurial environment and work effectively across global teams. Preferred Qualifications:Experience with thrombectomy, vascular intervention, pulmonary embolism, structural heart, or electrophysiology technologies. Prior experience supporting regulatory expansion into Europe, the Middle East, and emerging international markets. Experience participating in FDA meetings, regulatory inspections, and Notified Body audits.<br>Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.<br>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing Nav IQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar.<br>ABOUT SHIFAMEDFounded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.<br>Description:<br>This Manager / Sr. Manager, Regulatory Affairs will serve as a key member of the cross-functional team, partnering closely with Clinical, Quality, R&D, and Executive Leadership to support U. S. regulatory activities and lead global clinical studies and international market expansion. The ideal candidate brings strong FDA medical device experience combined with hands-on knowledge of international regulatory pathways, agency interactions, and clinical study support across Europe, the Middle East, and other global markets. This is a unique opportunity to help shape regulatory strategy for a clinical-stage medical device company as it expands global clinical activities, and prepares for international commercialization.<br>Responsibilities, Skills & Hands-On Experience:<br>Regulatory Strategy & Product Development:Develop and execute global regulatory strategies for Akura Medical's thrombectomy and catheter-based cardiovascular technologies. Serve as regulatory lead on cross-functional product development teams from concept through commercialization. Provide regulatory guidance on design controls, risk management, verification and validation activities, labeling, and product changes. Partner with Quality and R&D teams to ensure compliance with FDA, MDR, ISO 13485, and applicable international requirements. FDA Regulatory Affairs Lead preparation, review, and submission of U. S. regulatory filings, including IDE's, 510(k)'s, supplements, and other regulatory submissions as applicable. Monitor evolving FDA requirements and assess impact on development and commercialization plans. International Regulatory Expansion Develop regulatory strategies and market access plans for Europe, the Middle East, and other international markets. Support CE Mark and MDR-related activities in partnership with Notified Bodies and external regulatory consultants. Lead country-specific registration activities and regulatory submissions across key international markets including Qatar, UAE, Saudi Arabia, and other MENA countries. Establish and maintain relationships with regulatory authorities, notified bodies, and international regulatory partners. Clinical & Regulatory Operations Partner closely with Clinical Affairs to support global clinical studies, including IDE, PMCF, registries, and post-market studies. Provide regulatory guidance on protocol development, clinical study design, and regulatory approval pathways. Support regulatory submissions associated with clinical trial approvals across multiple countries and regions. Participate in investigator meetings, regulatory inspections, audits, and agency interactions. Agency Interactions & Compliance Represent the company during interactions with FDA, Notified Bodies, Ministries of Health, and other regulatory authorities. Support preparation for regulatory inspections and audits. Maintain awareness of evolving global regulatory requirements and communicate potential impacts to leadership. Contribute to regulatory intelligence activities and long-term market expansion planning. Cross-Functional Leadership Collaborate with Clinical, Quality, Manufacturing, Supply Chain, and R&D teams to ensure regulatory requirements are incorporated throughout the product lifecycle. Provide regulatory leadership for change assessments, design modifications, and lifecycle management activities. Support Executive Leadership with regulatory risk assessments, timelines, and strategic planning.<br>Qualifications & Experience:Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or related field.10+ years of Regulatory Affairs experience within the medical device industry; cardiovascular, endovascular, or interventional products strongly preferred. Direct experience with FDA medical device submissions, including IDE's, PMA's, 510(k)'s, or PMA supplements. Experience supporting clinical-stage medical device programs and global clinical studies. Working knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304, and international regulatory frameworks. Experience interacting directly with regulatory agencies, notified bodies, and international health authorities. Familiarity with MENA regulatory pathways (Saudi SFDA, UAE MOHAP/DOH, Qatar MOPH, etc.) is highly desirable. Strong understanding of design controls, risk management, clinical evidence requirements, and regulatory strategy development. Excellent written, verbal, and presentation skills. Ability to thrive in a fast-paced, entrepreneurial environment and work effectively across global teams. Preferred Qualifications:Experience with thrombectomy, vascular intervention, pulmonary embolism, structural heart, or electrophysiology technologies. Prior experience supporting regulatory expansion into Europe, the Middle East, and emerging international markets. Experience participating in FDA meetings, regulatory inspections, and Notified Body audits.<br>Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.<br>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing Nav IQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use. Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar.<br>ABOUT SHIFAMEDFounded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.<br>Description:<br>This Manager / Sr. Manager, Regulatory Affairs will serve as a key member of the cross-functional team, partnering closely with Clinical, Quality, R&D, and Executive Leadership to support U. S. regulatory activities and lead global clinical studies and international market expansion. The ideal candidate brings strong FDA medical device experience combined with hands-on knowledge of international regulatory pathways, agency interactions, and clinical study support across Europe, the Middle East, and other global markets. This is a unique opportunity to help shape regulatory strategy for a clinical-stage medical device company as it expands global clinical activities, and prepares for international commercialization.<br>Responsibilities, Skills & Hands-On Experience:<br>Regulatory Strategy & Product Development:Develop and execute global regulatory strategies for Akura Medical's thrombectomy and catheter-based cardiovascular technologies. Serve as regulatory lead on cross-functional product development teams from concept through commercialization. Provide regulatory guidance on design controls, risk management, verification and validation activities, labeling, and product changes. Partner with Quality and R&D teams to ensure compliance with FDA, MDR, ISO 13485, and applicable international requirements. FDA Regulatory Affairs Lead preparation, review, and submission of U. S. regulatory filings, including IDE's, 510(k)'s, supplements, and other regulatory submissions as applicable. Monitor evolving FDA requirements and assess impact on development and commercialization plans. International Regulatory Expansion Develop regulatory strategies and market access plans for Europe, the Middle East, and other international markets. Support CE Mark and MDR-related activities in partnership with Notified Bodies and external regulatory consultants. Lead country-specific registration activities and regulatory submissions across key international markets including Qatar, UAE, Saudi Arabia, and other MENA countries. Establish and maintain relationships with regulatory authorities, notified bodies, and international regulatory partners. Clinical & Regulatory Operations Partner closely with Clinical Affairs to support global clinical studies, including IDE, PMCF, registries, and post-market studies. Provide regulatory guidance on protocol development, clinical study design, and regulatory approval pathways. Support regulatory submissions associated with clinical trial approvals across multiple countries and regions. Participate in investigator meetings, regulatory inspections, audits, and agency interactions. Agency Interactions & Compliance Represent the company during interactions with FDA, Notified Bodies, Ministries of Health, and other regulatory authorities. Support preparation for regulatory inspections and audits. Maintain awareness of evolving global regulatory requirements and communicate potential impacts to leadership. Contribute to regulatory intelligence activities and long-term market expansion planning. Cross-Functional Leadership Collaborate with Clinical, Quality, Manufacturing, Supply Chain, and R&D teams to ensure regulatory requirements are incorporated throughout the product lifecycle. Provide regulatory leadership for change assessments, design modifications, and lifecycle management activities. Support Executive Leadership with regulatory risk assessments, timelines, and strategic planning.<br>Qualifications & Experience:Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or related field.10+ years of Regulatory Affairs experience within the medical device industry; cardiovascular, endovascular, or interventional products strongly preferred. Direct experience with FDA medical device submissions, including IDE's, PMA's, 510(k)'s, or PMA supplements. Experience supporting clinical-stage medical device programs and global clinical studies. Working knowledge of EU MDR, ISO 13485, ISO 14971, IEC 62304, and international regulatory frameworks. Experience interacting directly with regulatory agencies, notified bodies, and international health authorities. Familiarity with MENA regulatory pathways (Saudi SFDA, UAE MOHAP/DOH, Qatar MOPH, etc.) is highly desirable. Strong understanding of design controls, risk management, clinical evidence requirements, and regulatory strategy development. Excellent written, verbal, and presentation skills. Ability to thrive in a fast-paced, entrepreneurial environment and work effectively across global teams. Preferred Qualifications:Experience with thrombectomy, vascular intervention, pulmonary embolism, structural heart, or electrophysiology technologies. Prior experience supporting regulatory expansion into Europe, the Middle East, and emerging international markets. Experience participating in FDA meetings, regulatory inspections, and Notified Body audits.<br>Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job-related knowledge, location, skills, experience, relevant education, and training/certifications.<br>NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to hr@shifamed.com.
Job Description<br><br>At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry. To remain competitive in this rapidly changing landscape, organizations require regulatory affairs professionals who can navigate complex and fast-changing laws, regulations, and public policies across the globe.<br><br>In this context, we are looking for regulatory affairs experts in the med-tech space to play a key role in driving Oracle's success and competitiveness in the healthcare and life sciences sector.<br><br>You will work primarily with the Oracle Health & Life Sciences business units but will also interact with all Oracle business units selling products to the health and life sciences industries. This role requires an individual who can keep up with the fast-paced environment of software development and an evolving regulatory landscape. For this role we are seeking a regulatory strategist who is collaborative, a creative problem solver, and dedicated to excellence in their work.<br><br>What You’ll Do:<br><br> Work closely with Oracle’s product engineering teams to assess product functionality and develop regulatory strategy for Middle East and Africa countries. Collaborate cross-functionally to create and manage submissions for health authorities including SFDA (Saudi Arabia), MOHAP (United Arab Emirates), MOPH (Qatar), NHRA (Bahrain), SAHPRA (South Africa), NAFDAC (Nigeria), EDA (Egypt) and PPB (Kenya) ensuring on going compliance with regulatory authorities. Maintain regulatory documentation, technical files, and post market surveillance activities ensuring ongoing compliance with applicable regulations. Support internal and external audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies. Serve as a subject matter expert for internal clients with interpretation of applicable standards, regulations, and use of the quality management system. Manage regulatory and compliance related projects for Health-related products. Review and recommend changes to labeling, marketing materials, clinical protocols, design processes, and procedures to maintain regulatory and quality compliance. Maintain compliance with changing regulatory requirements across global markets that impact to our businesses, regulatory affairs function, and quality/compliance programs. Build effective working relationships with regulatory agencies, affiliates, and cross-functional stakeholders to support aligned and practical regulatory outcomes. <br><br><br>Preferred Qualifications:<br><br> Bachelor’s degree in pharmacy, Biology, Biomedical Engineering, Engineering, Life Sciences, Health Sciences, or a related field. Experience with SaMD in areas such as Regulatory Affairs, Quality Compliance, Product Development, etc. in medical device industry or equivalent. Experience authoring submissions across assigned Middle East and Africa market required. Experience with sustaining and new product development is ideal. Comprehensive knowledge of regulatory requirements and processes across Middle East and Africa countries, with demonstrated experience interpreting local regulations and supporting market access, lifecycle compliance, and health authority engagements. Strong problem-solving, planning, and organizational skills, with the ability to manage multiple priorities and work independently in a fast-paced, cross-cultural environment. Experience in working within a quality management system, preferably with ISO 13485, ISO 14971, 60601, 62304, 21 CFR parts 1000/1001, Understands continual improvement and risk management. Excellent written and verbal communication skills. Experience engaging with regional trade associations, industry groups, or regulatory forums. Ability to adjust and adapt to changing priorities in a dynamic environment. Ability to perform in a fast-paced and continually evolving business environment. <br><br><br>Responsibilities<br><br>Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends appropriate changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. May serve as point of contact for interactions with regulatory agencies for defined matters. Support the creation of a comprehensive risk management and/or quality management, and regulatory oversight program, including specifications for product and service design aligned with Oracle Software Security Assurance and Security Architecture, and/or Quality Management systems. Review specifications. Develop training for GBU development, cloud services, services and operations teams on industry regulatory specifications applicable to their products and services. Execute risk assessments and evaluate risks to the business and develop risk mitigation strategies. Identify industry requirements applicable to Oracle GBUs, and work with members of GBU development, cloud services, services and operations teams to incorporate applicable industry regulatory standards, Oracle security and/or quality policies and customer-contractual obligations into GBU processes and standards. Coordinate industry and regulatory certifications, including managing certification vendors (e.g., PCI, HIPAA,HITECH, ISO, SOC2). Build security documentation and collateral for customers and internal users allowing security to be a differentiator in this GBUs. Build management level metrics and reporting for activities that are owned by the Risk Manager. Execute a vendor security and/or quality management program.<br><br>Qualifications<br><br>Career Level - IC4<br><br>About Us<br><br>Only Oracle brings together the data, infrastructure, applications, and expertise to power everything from industry innovations to life-saving care. And with AI embedded across our products and services, we help customers turn that promise into a better future for all. Discover your potential at a company leading the way in AI and cloud solutions that impact billions of lives.<br><br>True innovation starts when everyone is empowered to contribute. That’s why we’re committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs.<br><br>We’re committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_mb@oracle.com or by calling 1-888-404-2494 in the United States.<br><br>Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans’ status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
Scale is powering the generative AI wave by providing the data and infrastructure for companies to build large-scale foundation models. AI is rapidly changing the world, and Scale is growing to meet that rapid demand across global markets, including accelerating public sector business across EMEA.<br><br>Scale seeks an EMEA Assurance Lead to drive assurance programs across Scale's EMEA public sector and commercial business. Reporting to the Head of Global Assurance, this is a hands-on individual contributor role with significant autonomy. You will independently design and own EMEA-specific controls within Scale's global assurance framework, while staying tightly aligned with the global controls library and reporting cadences. You will be part of the global GRC team and work across Global Public Sector, Enterprise, Security, Engineering, Product, and Legal to deliver region-specific authorizations, certifications, and customer assurance outcomes across EMEA, with a focus on the GCC, UK, and EU markets.<br><br>You Will<br><br>Lead region-specific assurance programs across the GCC and UK, including Qatar NCSA National Information Assurance (NIA), KSA NCA Essential Cybersecurity Controls (ECC), UAE DESC Information Security Regulation (ISR), and UK Cyber Essentials Plus, Defence Cyber Certification (DCC), and NCSC Secure by Design (SdB). You will own controls mapping, evidence collection, gap analysis, certification timelines, and submission management for each, working with accredited external assessors where required. Work with the global GRC team to maintain and renew Scale's existing certifications and obtain new ones, including SOC 2, ISO 27001, ISO 42001, and ISO 9001. You will also own their extension to EMEA and international operations, including for NATO-aligned defence tenders. Design and maintain EMEA-specific controls, adapting Scale's global controls framework to sovereign regulatory and customer requirements, including data residency and sector-specific requirements (e.g., health sector), identifying where existing controls satisfy local standards and where new controls or evidence artifacts are needed. Set priorities and operating cadences for EMEA assurance workflows, including intake, evidence collection, control owner follow-up, remediation tracking, and deadline management, reporting progress through Scale's global assurance dashboards. Support EMEA public sector customer assurance activities, including security questionnaires, compliance due diligence responses, customer-facing assurance discussions, and compliance input to bid and capture processes where assurance readiness is a procurement gate. Partner with Legal on EMEA contract-driven assurance obligations, data protection and AI governance compliance intersections (e.g., GDPR, Qatar PDPPL, EU AI Act), and sensitive escalations involving sovereign regulators. Manage relationships with EMEA-based external auditors, assessors, certification bodies, and regulatory counterparts. Support internal and external audits across EMEA and report into the Head of Global Assurance on program health, key risks, certification timelines, and regional regulatory developments.<br><br>Ideally, You’d Have<br><br>7+ years of experience in cybersecurity compliance, GRC, public sector assurance, IT audit, cloud security, or related roles, with meaningful exposure to EMEA markets. Experience executing government or public sector assurance programs in the UK, EU, or GCC, including working with external certification bodies, government assessors, or authorizing officials. Deep familiarity with one or more of: UK Cyber Essentials/Cyber Essentials+, ISO 27001, ISO 9001, ISO 42001, SOC 2, or equivalent frameworks, and with sovereign security regimes in the GCC (e.g., Qatar NCSA NIA, KSA SCCC/NCA, UAE DESC/NESA). Familiarity with relevant EMEA data protection and AI governance requirements (e.g., GDPR, PDPPL, EU AI Act) and how they translate into technical and organisational controls. Experience managing controls mapping, evidence collection, remediation tracking, and audit coordination across distributed engineering and infrastructure teams. Experience with cloud environments (one or more of: AWS, Azure, GCP) and the ability to assess cloud architecture against compliance requirements. Strong communication skills, sound judgment on escalation, and the ability to operate autonomously in a region while maintaining alignment with a global program.<br><br>Nice to Have<br><br>Relevant certifications such as CISSP, CISM, CISA, ISO 27001 Lead Auditor, ISO 42001 Internal Auditor, or CCSP. Experience with NATO information assurance standards or defence procurement prerequisites. Familiarity with EMEA health-sector or medical-device regulatory requirements, particularly in the GCC and the UK. Working knowledge of Arabic. UK SC or DV clearance, or eligibility for equivalent EMEA government security clearances. Experience at a Big 4 firm or in a high-growth technology company.<br><br>For those applying based in Qatar: Residency and employment in Qatar requires certain permissions (visa and permits) issued by the Qatari authorities. As part of the application process, candidates will be asked to provide personal information, including residency status and nationality, which is required for visa processing. This information is collected solely for immigration compliance purposes and will be not used as a criterion in any hiring decision unless such use is lawfully permitted. Visa issuance is at the discretion of the Qatari authorities. If you are successful in your application, you will be required to provide the documentation requested by Scale and the authorities to obtain the necessary permissions for you to live and work in Qatar, and Scale will work with successful candidates to support the visa application process.<br><br>PLEASE NOTE: Our policy requires a 90-day waiting period before reconsidering candidates for the same role. This allows us to ensure a fair and thorough evaluation of all applicants.<br><br>About Us:<br><br>At Scale, our mission is to develop reliable AI systems for the world's most important decisions. Our products provide the high-quality data and full-stack technologies that power the world's leading models, and help enterprises and governments build, deploy, and oversee AI applications that deliver real impact. We work closely with industry leaders like Meta, Ernst & Young, Mayo Clinic, Time Inc., the Government of Qatar, and U. S. government agencies including the Army and Air Force. We are expanding our team to accelerate the development of AI applications.<br><br>We believe that everyone should be able to bring their whole selves to work, which is why we are proud to be an inclusive and equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability status, gender identity or Veteran status. <br><br>We are committed to working with and providing reasonable accommodations to applicants with physical and mental disabilities. If you need assistance and/or a reasonable accommodation in the application or recruiting process due to a disability, please contact us at accommodations@scale.com. Please see the United States Department of Labor's Know Your Rights poster for additional information.<br><br>We comply with the United States Department of Labor's Pay Transparency provision. <br><br>PLEASE NOTE: We collect, retain and use personal data for our professional business purposes, including notifying you of job opportunities that may be of interest and sharing with our affiliates. We limit the personal data we collect to that which we believe is appropriate and necessary to manage applicants’ needs, provide our services, and comply with applicable laws. Any information we collect in connection with your application will be treated in accordance with our internal policies and programs designed to protect personal data. Please see our privacy policy for additional information.