وظائف هندسة طبية - الدوحة قطر
١٨ وظائف شاغرة
<p>ملخص الوظيفة</p><p> </p><p>نحن نبحث عن مساعد إداري مبتدئ للرعاية الصحية يتمتع بروح المبادرة والتنظيم والدقة لدعم أنشطتنا الإدارية وأنشطة عروض الأسعار والمشتريات والمناقصات، والمساهمة في التشغيل اليومي السلس لمكتبنا.</p><p> </p><p>هذا المنصب مناسب للخريجين الجدد أو المرشحين الذين لديهم خبرة تصل إلى عامين والمهتمين بتطوير مسارهم المهني في قطاع توريدات الرعاية الصحية ومشتريات المعدات الطبية.</p><p> </p><p>المسؤوليات الرئيسية</p><p> </p><p>* المساعدة في إعداد عروض الأسعار ووثائق المناقصات.</p><p>* المساعدة في طلبات عرض الأسعار (RFQs) والتواصل مع الموردين.</p><p>* الحفاظ على سجلات وأنظمة حفظ منظمة.</p><p>* التنسيق مع الموردين والعملاء.</p><p>* دعم أنشطة المشتريات والأنشطة الإدارية.</p><p>* إعداد التقارير ومتابعة مهام المكتب اليومية.</p><p>* المساعدة في أوامر الشراء ووثائق التسليم والسجلات ذات الصلة.</p><p>* دعم مسؤول المناقصات والشؤون الإدارية الأول وفريق الإدارة حسب الحاجة.</p><p> </p><p>المتطلبات</p><p> </p><p>* خريجون جدد أو مرشحون لديهم خبرة تصل إلى سنتين.</p><p>* يفضل الحصول على شهادة/دبلوم في الهندسة الطبية الحيوية، أو العلوم الطبية، أو الرعاية الصحية، أو سلسلة التوريد، أو إدارة الأعمال، أو أي مجال ذي صلة.</p><p>* تعتبر الخبرة السابقة في شركة توريدات طبية أو رعاية صحية ميزة إضافية.</p><p>* مهارات تواصل وكتابة جيدة باللغة الإنجليزية.</p><p>* إتقان برامج Microsoft Office، وخاصة Word و Excel.</p><p>* مهارات تنظيمية قوية واهتمام بالتفاصيل.</p><p>* اتجاه إيجابي، ورغبة في التعلم، وقدرة على التطوير المهني.</p><p>* القدرة على العمل ضمن فريق والوفاء بالمواعيد النهائية.</p><p> </p><p>الراتب والمزايا</p><p> </p><p>* الراتب المبدئي: 3,000 – 4,000 ريال قطري، حسب المؤهلات والخبرة.</p><p>* مراجعة سنوية للراتب.</p><p>* مكافأة تعتمد على الأداء.</p><p>* إجازة سنوية لمدة 30 يوماً تقويمياً.</p><p>* تذكرة طيران ذهاب وإياب كل عامين.</p><p>* فرص ممتازة للنمو الوظيفي والتطوير المهني.</p><p> </p><p>لماذا تنضم إلى RQM؟</p><p> </p><p>* انضم إلى شركة رعاية صحية متنامية ومتخصصة في قطر.</p><p>* طور مسيرتك المهنية في قطاع توريدات الرعاية الصحية ومشتريات المعدات الطبية.</p><p>* اعمل جنباً إلى جنب مع مهنيين ذوي خبرة وموردين دوليين.</p><p>* اكتسب خبرة عملية في مجال المناقصات والمشتريات وقطع غيار المعدات الطبية والمستهلكات الطبية.</p><p>* كن جزءاً من شركة لديها خطط نمو وتوسع طويلة الأجل.</p><p> </p><p>⸻</p><p> </p><p> </p><p>مثال:</p><p>طلب توظيف – مسؤول أول للشؤون الإدارية والمناقصات في الرعاية الصحية</p><p> </p><p>أو</p><p> </p><p>طلب توظيف – مساعد إداري مبتدئ للرعاية الصحية</p><p> </p><p>سيتم الاتصال بالمرشحين الذين يتم اختيارهم فقط.</p>
<ul><li><p>تثبيت، فحص، معايرة، صيانة وإصلاح المعدات الطبية والبيوميية.</p></li><li><p>إجراء الصيانة الوقائية والتصحيحية للأجهزة الطبية.</p></li><li><p>تشخيص فشل المعدات وتنسيق الإصلاحات مع الشركات المصنعة أو مزودي الخدمة.</p></li><li><p>إجراء اختبارات السلامة والأداء للمعدات الطبية.</p></li><li><p>التأكد من امتثال المعدات لمعايير السلامة المعمول بها واللوائح وسياسات المستشفى.</p></li><li><p>التحقيق في حوادث المعدات والتوصية بإجراءات تصحيحية أو وقائية.</p></li><li><p>التعاون مع الفرق الإكلينيكية والتقنية لتحديد متطلبات المعدات والتقنية.</p></li><li><p>المساعدة في تقييم المخاطر، والتدقيق، وأنشطة تحسين الجودة.</p></li><li><p>مواكبة التطورات في أجهزة الطب وتقنية الرعاية الصحية واللوائح ذات الصلة.</p></li></ul><p><br></p><p><strong>المؤهلات:</strong><br></p><ul><li><p>درجة البكالوريوس في الهندسة البيومية.</p></li><li><p>خبرة لا تقل عن 3–5 سنوات في السوق القطري.</p></li><li><p>معرفة قوية بالمعدات الطبية والإلكترونيات وأجهزة القياس والأنظمة الميكانيكية الأساسية.</p></li><li><p>استعداد للسفر بشكل واسع داخل قطر لزيارة العملاء وأنشطة تطوير الأعمال.</p></li><li><p>فهم لمعايير سلامة الأجهزة الطبية وإجراءات الصيانة.</p></li><li><p>مهارات قوية في استكشاف الأخطاء وتحليلها.</p></li><li><p>المشاركة في المعارض والمؤتمرات والندوات وغيرها من الأنشطة الترويجية لزيادة الوعي بالعلامة التجارية.</p></li><li><p>القدرة على العمل بشكل فعال مع الأطباء والممرضين والفنيين والموردين وغيرها من الأقسام.</p></li></ul><p><strong>الملف الشخصي المرغوب فيه للمرشح</strong></p><p>الشهادات أو التدريبات المهنية من مصنعي الأجهزة الطبية تعتبر ميزة.</p>
<section><p class="heading jdMain">وصف الوظيفة</p><p class="heading">الأدوار والمسؤوليات</p><div class="paragraph"><p><b>خلفية في علوم الطب الحيوي / الصيدلة</b></p><p><br></p><ul style="font-size: 11px;"><li style="font-size: 11px;">3-5 سنوات خبرة في قطر</li><li style="font-size: 11px;">الخبرة في الطوارئ/ الطب الرياضي/ CSSD/ الأشعة مفضلة.</li><li style="font-size: 11px;">رخصة قيادة مطلوبة.</li></ul></div></section><section><p class="heading">الملف المرشح المطلوب</p><p class="paragraph"></p><ul><li><br></li></ul><p></p></section>
<p></p><ul><li><p>الترويج لمحفظة الخدمات الجمالية المهنية لـ Promoitalia للأطباء المختصين وجريئات التجميل.</p></li><li><p>بناء علاقات قوية والحفاظ عليها مع المتخصصين في الرعاية الصحية.</p></li><li><p>إجراء زيارات دورية للعيادات وتحقيق أهداف المبيعات.</p></li><li><p>توفير معرفة المنتج والعروض والدعم الإكلينيكي للأطباء.</p></li><li><p>تحديد فرص عمل جديدة وتوسيع قاعدة العملاء.</p></li><li><p>متابعة اتجاهات السوق ونشاطات المنافسين.</p></li><li><p>إعداد تقارير المبيعات والحفظ على سجلات العملاء.</p></li></ul><p><strong>الملف المرغوب فيه للمرشح</strong></p><ul><li><p>خبرة من 2–3 سنوات كممثل طبي، ويفضل في مجال الجلدية/التجميل.</p></li><li><p>درجة البكالوريوس في الصيدلة، التمريض، العلوم الطبية الحيوية، أو مجال ذو صلة.</p></li><li><p>مهارات تواصل وعرض وتفاوض قوية.</p></li><li><p>قابلية تحقيق النتائج ولديك شغف بالمبيعات وبناء علاقات مع الأطباء.</p></li><li><p>معرفة جيدة بالمنتجات والإجراءات التجميلية مفضلة.</p></li><li><p>الطلاقة في اللغة الإنجليزية مع هوية قطرية سارية ورخصة قيادة.</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 تُمكّن موجة الذكاء الاصطناعي التوليدي من خلال توفير البيانات والبنية التحتية للشركات لبناء نماذج أساسية واسعة النطاق. يتغير عالم AI بسرعة، وتقوم Scale بالنمو لتلبية هذه الطلبات السريعة عبر الأسواق العالمية، بما في ذلك توسيع الأعمال في القطاع العام عبر منطقة أوروبا والشرق الأوسط وأفريقيا. تسعى Scale إلى تعيين قائد Assurance في أوروبا والشرق الأوسط وأفريقيا لدفع برامج الضمان عبر قطاع Scale العام وقطاعه التجاري في هذه المنطقة. وبالتبعية لرئيس Assurance العالمي، هذا دور مساهم فاعل بيده عمله وبسلطة كبيرة. ستقوم بتصميم وامتلاك ضوابط خاصة بمنطقة أوروبا والشرق الأوسط وأفريقيا ضمن إطار عمل الضمان العالمي لـ Scale، مع البقاء متماشياً بشكل وثيق مع مكتبة الضوابط العالمية وجداول التقارير. ستكون جزءاً من فريق GRC العالمي وتعمل عبر القطاع العام العالمي والمؤسسات والأمن والهندسة والمنتج والشؤون القانونية لتوفير تراخيص وتصديقات ونتائج ضمان للزبائن خاصة بالإقليم في أوروبا والشرق الأوسط وأفريقيا، مع تركيز على أسواق دول مجلس التعاون الخليجي والمملكة المتحدة والاتحاد الأوروبي. ستقوم بـ<br><br>المهمة الرئيسية<br><br>قيادة برامج الضمان الإقليمية عبر الخليج والمملكة المتحدة، بما في ذلك NCSA قطر للمعلومات الأساسية (NIA)، NCA السعودية لضوابط الأمن السيبراني الأساسية (ECC)، DESC الإمارات للتنظيم الأمني للمعلومات (ISR)، وUK Cyber Essentials Plus وDefence Cyber Certification (DCC) وNCSC Secure by Design (SdB). ستتولى رسم خرائط الضوابط وجمع الأدلة وتحليل الثغرات وما إلى ذلك، مع إدارة جداول التصديق والتقديم للمراجعين المعتمدين عند الحاجة. العمل مع فريق GRC العالمي للحفاظ وتجديد الشهادات الحالية لـ Scale والحصول على شهادات جديدة، بما في ذلك SOC 2 وISO 27001 وISO 42001 وISO 9001. كما ستتولى توسيع نطاقها إلى العمليات الدولية وعلى مستوى أوروبا والشرق الأوسط وأفريقيا، بما في ذلك للمناقصات الدفاعية المرتبطة بـ NATO. تصميم والحفاظ على ضوابط خاصة بـ EMEA، وتكييف إطار الضوابط العالمي لـ Scale مع المتطلبات التنظيمية والزبونية السارية، بما في ذلك الإقامة البيانية ومتطلبات القطاع (مثلاً قطاع الصحة)، وتحديد أماكن تطابق الضوابط الحالية مع المعايير المحلية وأين تكون هناك حاجة لضوابط جديدة أو أدلة إثبات. تحديد الأولويات وتوقيتات تشغيل لسير عمل ضمان EMEA، بما في ذلك الاستلام وجمع الأدلة والمتابعة مع مالكي الضوابط وتتبع الإصلاحات وإدارة المواعيد النهائية، مع تقارير التقدم عبر لوحات القيادة العالمية للضمان لدى Scale. دعم أنشطة ضمان عملاء القطاع العام في EMEA، بما في ذلك الاستبيانات الأمنية وردود إجراءات التوافق ومسارات نقاش ضمان أمام العملاء وإدخال التوافق في عروض العطاءات وعمليات الالتقاط حيث تمثل الجاهزية للضمان حاجزاً للمشتريات. التعاون مع الشؤون القانونية بشأن التزامات الضمان القائمة على العقود في EMEA والعلاقات المتقاطعة مع حماية البيانات وحوكمة AI (مثل GDPR وQatar PDPPL وEU AI Act) والارتفاعات الحساسة التي تشمل الجهات التنظيمية السيادية. إدارة العلاقات مع مدققين ومقييمين وجهات اعتماد خارجية ومقابلات تنظيمية في EMEA. دعم عمليات التدقيق الداخلية والخارجية عبر EMEA والتقرير إلى رئيس Assurance العالمي عن صحة البرنامج والمخاطر الرئيسية وجداول زمن التصديق والتطورات التنظيمية الإقليمية. <br><br>من الأفضل أن تمتلك<br><br>7+ سنوات خبرة في امتثال الأمن السيبراني أو GRC أو ضمان القطاع العام أو تدقيق تكنولوجيا المعلومات أو أمن السحابة أو أدوار ذات صلة، مع تعرض مهم لأسواق EMEA. خبرة في تنفيذ برامج ضمان حكومية أو قطاع عام في المملكة المتحدة أو الاتحاد الأوروبي أو مجلس التعاون الخليجي، بما في ذلك العمل مع هيئات التصديق الخارجية أو مقيمين حكوميين أو مسؤولين مخولين. دراية عميقة بأحد أو أكثر من: UK Cyber Essentials/Cyber Essentials+، ISO 27001، ISO 9001، ISO 42001، SOC 2، أو أطر مكافئة، ومع أنظمة الأمن السيادي في الخليج (مثلاً قطر NCSA NIA، المملكة العربية السعودية SCCC/NCA، الإمارات DESC/NESA). إلمام بمطالب حماية البيانات وحوكمة الذكاء الاصطناعي السارية في EMEA وكيف تترجم إلى ضوابط تقنية وتنظيمية. خبرة في إدارة خرائط الضوابط وجمع الأدلة وتتبع الإصلاح وتنسيق التدقيق عبر فرق الهندسة والبنية التحتية الموزعة. خبرة في بيئات السحابة (AWS/Firebase/Azure/GCP) والقدرة على تقييم بنية السحابة مقابل متطلبات الامتثال. مهارات تواصل قوية وحكم سليم في التصعيد والقدرة على العمل باستقلالية في منطقة مع الحفاظ على التوافق مع برنامج عالمي. <br><br>مفضل وجوده<br><br>شهادات ذات صلة مثل CISSP وCISM وCISA وISO 27001 Lead Auditor وISO 42001 Internal Auditor أو CCSP. خبرة في معايير ضمان المعلومات لحلف الناتو أو متطلبات الشراء الدفاعي. إلمام بمتطلبات تنظيمية خاصة بقطاع الصحة في EMEA أو الأجهزة الطبية، خاصة في الخليج والمملكة المتحدة. معرفة عملية بالعربية. تصريح UK SC أو DV، أو الأهلية للحصول على تصاريح أمن حكومية معادلة في EMEA. خبرة في شركة Big 4 أو شركة تقنية ذات نمو عالي. <br><br>بالنسبة للراغبين في التقديم من قطر: الإقامة والعمل في قطر يتطلبان تصاريح (فيزا وتصاريح) معينة تصدرها السلطات القطرية. كجزء من عملية التقديم، سيُطلب من المرشحين تقديم معلومات شخصية، بما في ذلك وضع الإقامة والجنسية، وهو مطلوب لمعالجة الفيزا. يتم جمع هذه المعلومات فقط لأغراض الامتثال للهجرة ولن تُستخدم كمعيار في أي قرار توظيف ما لم يكن ذلك مسموحاً قانونياً. إصدار الفيزا بتقدير من السلطات القطرية. إذا نجحت في التقديم، سيتعين عليك تقديم الوثائق المطلوبة من Scale والسلطات للحصول على التصاريح اللازمة للعيش والعمل في قطر، وستتعاون Scale مع المرشحين الناجحين لدعم عملية طلب الفيزا. <br><br>يرجى ملاحظة: سياساتنا تشترط فتره انتظار 90 يوماً قبل إعادة النظر في المرشحين لنفس الدور. وذلك لضمان تقييم عادل وشامل لجميع المتقدمين. <br>عنّا:<br><br>في Scale، رسالتنا هي تطوير أنظمة AI موثوقة للقرارات الأكثر أهمية في العالم. منتجاتنا توفر البيانات عالية الجودة وتقنيات كاملة النطاق التي تدفع نماذج القياس الرائدة في العالم، وتساعد الشركات والحكومات على بناء وتوزيع ومراقبة تطبيقات AI التي تحقق أثرًا حقيقيًا. نعمل بشكل وثيق مع قادة الصناعة مثل Meta وErnst & Young وMayo Clinic وTime Inc. وحكومة قطر والجهات الأمريكية بما في ذلك الجيش والقوات الجوية. نحن نقوم بتوسيع فريقنا لتسريع تطوير تطبيقات AI. <br><br>نؤمن بأن على الجميع أن يتمكنوا من جلب أنفسهم كاملة للعمل، وهذا سبب فخرنا كمكان عمل شامل ومتكافئ الفرص. نحن ملتزمون بمبدأ المساواة في فرص العمل بغض النظر عن العرق أو اللون أو الأصل أو الدين أو الجنس أو الأصل القومي أو التوجه الجنسي أو العمر أو الجنسية أو الحالة الاجتماعية أو الإعاقة أو الهوية الجنسية أو حالة المحارب القديم. <br><br>نلتزم بتوفير التسهيلات المعقولة للمتقدمين ذوي الإعاقات الجسدية والذهنية. إذا كنت بحاجة إلى مساعدة و/أو تسهيل معقول في عملية التقديم أو التوظيف بسبب الإعاقة، يرجى التواصل معنا على accommodations@scale.com. الرجاء الاطلاع على ملصق Know Your Rights الخاص بوزارة العمل الأمريكية لمعلومات إضافية.<br><br>نلتزم بمزودي شفافية الأجور للوزارة الأمريكية للعمل. <br><br>يرجى ملاحظة: نجمع ونحتفظ ونستخدم البيانات الشخصية لأغراض أعمالنا المهنية، بما في ذلك إعلامك بفرص عمل قد تهمك ومشاركتها مع شركائنا. نحد من البيانات الشخصية التي نجمعها إلى ما نراه مناسباً وضرورياً لإدارة احتياجات المتقدمين، وتقديم خدماتنا، والامتثال للقوانين المعمول بها. أي معلومات نجمعها فيما يتعلق بطلبك ستعامل وفق سياساتنا وبرامجنا الداخلية المصممة لحماية البيانات الشخصية. رجاءً اطلع على سياسة الخصوصية لمعلومات إضافية.