Senior CER Project Manager - Regulatory & Medical Devices
Abbott Laboratories
Abbott in the United States is seeking a Senior Project Manager/Clinical Evaluations to support regulatory submissions for medical devices. This on-site role focuses on CER development, review, and regulatory strategy across EU MDR requirements, with cross-functional collaboration among R&D, Regulatory Affairs, and Quality teams. The CER PM will lead writing and oversight of CERs, CEPs, PMCF plans, and related documents, ensuring safety and performance data support lifecycle evaluations. #J-18808-Ljbffr Abbott
- ...DescriptionPrimary Function of Position:The Senior Project Manager, Clinical Affairs, plays a... ..., including R&D, Regulatory Affairs (RA), Clinical... ...deep familiarity with medical device development lifecycle as well... ...Clinical Evaluation Reports [CERs]), including metric reporting...SeniorMedical deviceLocal areaWorldwideFlexible hours
$90k - $180k
...: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted... ...in diagnostics, medical devices, nutritionals and... ...technology for the management and treatment of... ...We are looking for a Senior Project Manager/Clinical Evaluation... ...Evaluation Report (CER) Project Manager (PM)...SeniorMedical deviceWork experience placement- Abbott Laboratories is seeking a Senior Project Manager/Clinical Evaluation Reporting to lead CER activities for medical devices on-site in Santa Clara, Pleasanton, Atlanta, or... ...Clinical Evaluation Reports, and support regulatory submissions under EU MDR 2017/745,...SeniorMedical device
- ...continues with our one-of-a-kind management program designed to build... ...That Awaits You: The Senior Project Manager, Operations provides... ...Management System to ensure regulatory compliance.Understands and... ...in Engineering.6+ years of medical device, automotive, aerospace, or...SeniorMedical deviceFull time
- SI-BONE is seeking a Project Manager / Sr. Project Manager to lead portfolio initiatives from the Santa Clara, CA location. The role reports... ...timelines across multiple functions while maintaining regulatory and quality compliance. The position emphasizes analytical rigor...SeniorMedical device
- ...firm in California is seeking an experienced project manager to lead software development initiatives in the medical device and robotics sectors. Candidates should possess... ...in a related field, and familiarity with regulatory requirements. This role offers opportunities...SeniorMedical device
- ...digital ecosystem. Program Managers in Digital are... ...engineering, clinical and regulatory schedules, and ensure... ...People who understand how medical technology products... ..., overseeing critical projects, and delivering... ...highly technical medical devices from a software/digital...SeniorMedical deviceLocal areaWorldwideFlexible hours
$109k - $174.8k
...recognize their merit. Job Function: Project/Program Management Group Job Sub Function: Technology... ...calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic...SeniorMedical deviceFull timeTemporary workLocal area- Job Description The Senior Manager Logistics Compliance Trade Programs... ...track record of delivering projects that involve coordination... ...conducting audits for accuracy and regulatory adherence. Monitor... ...restrictions and communicate back to medical device business. Submit and...SeniorMedical deviceWork experience placementFlexible hours
- Join to apply for the Sr. Project Manager - Services PMO role at Intuitive . Get AI-powered... ...development. Present project updates to senior management. Qualifications Required... ...operations. Experience in operations, medical devices, or software preferred. Strong communication...SeniorMedical deviceFull timeWorldwide
- ...candidate brings strong project leadership, risk management, and operational excellence... ...reports to the Senior Director of Privacy Compliance... ...for implementing legal and regulatory requirements into practical... ...sciences, academic research or medical device.Advanced degree in law,...SeniorMedical deviceWork at officeLocal areaWorldwideFlexible hours3 days per week
- ...reports to Manger/Sr. Manager, Medical Sciences and requires... ...Clinical Evaluation Reports (CERs), with a potential for... ...product development, regulatory, post-market... ...therapeutic areas, competitor devices, current clinical/... ...utilizing appropriate project management tools.Serve...SeniorMedical deviceLocal areaWorldwideFlexible hours
$235k - $260k
...visit grail.com As Senior Corporate Counsel/... ...with your manager, will align with team... ...across Commercial, Medical Affairs, Clinical,... ...balancing legal and regulatory requirements with... ...pharmaceutical, medical device, or other life... ..., analytical, and project management skills,...SeniorMedical deviceFull timeWork at officeLocal areaWorldwideFlexible hours- Job Summary: Seeking a Senior Medical Device Quality & Compliance Engineer with expertise... ...Device Quality Systems, Regulatory Compliance, Design Transfer, Risk Management, and Quality Engineering. The... ...Continuous Improvement Strong project planning and execution skills....SeniorMedical device
- ...Intuitive Surgical, Inc. seeks a Counsel/Senior Counsel, IP to lead patent portfolio management, IP transactions, and IP counseling. You will partner with... ...protect insights in robotic-assisted surgery and medical devices. You will manage patent prosecution, support NDAs...SeniorMedical device
$150k - $240k
...efficient and accessible for all. We're searching for a Senior Technical Project Manager --- Safety Case (Vehicle / Hardware). We are searching... ...hardware domain (e.g. automotive, aerospace, industrial, medical devices). Proven program-management skills: planning, tracking,...SeniorMedical deviceWork at officeLocal area3 days per week- Intuitive Surgical seeks a Senior Human Factors Engineer for its Ion team. You will perform user-centered research, usability testing... ...existing products. You will collaborate with designers, engineers, regulatory and clinical teams to ensure usability and safety. The role...SeniorMedical device
- Cepheid, a Danaher operating company, is seeking a Senior Quality Engineer to drive quality across manufacturing and new product introduction in Sunnyvale and Newark, CA. You will develop risk-based strategies and ensure compliance with ISO 13485 and 21 CFR 820 while enabling...SeniorMedical device
- A medical technology company in Sunnyvale, California is seeking a Senior Manufacturing Engineer to lead product/process development and manufacturing support in the medical devices sector. The ideal candidate will have a background in mechanical or biomedical engineering...SeniorMedical device
- Abbott in Santa Clara, CA seeks a Senior Product Development Engineer to lead design verification activities for medical device systems. You will develop test methods, write protocols, investigate performance issues, and drive corrective actions in a fast-paced R&D environment...SeniorMedical device
- ...Outset Medical, a leading dialysis device innovator, seeks a Senior Microbiologist to lead microbiological safety across the product lifecycle. The role develops... ...leads testing and risk assessments, and ensures regulatory and quality compliance. Collaboration spans R&D,...SeniorMedical device
- Intuitive Surgical, Inc. in Sunnyvale, CA, seeks a Senior Quality Engineer to oversee end-to-end quality investigations across manufacturing... ...design activities. You will lead CAPA, risk assessment, and regulatory readiness, mentoring junior engineers and ensuring GMP/ISO/FDA...SeniorMedical device
- ...construct manufacturing equipment for minimally invasive medical devices. You will play a critical role in developing advanced manufacturing... ...in automated equipment design. You will also engage in project management and quality assurance processes to ensure all equipment...SeniorMedical device
- Intuitive Surgical is seeking a Senior Quality Engineer to oversee end-to-end quality investigations across design, manufacturing and... ...You will lead cross-functional teams, drive CAPAs, and ensure regulatory compliance. The role emphasizes data-driven improvements, risk...SeniorMedical device
$164k - $239k
...Compliance Priorities (ECPs), defining project-level scope and ensuring global support... ...integrated into corporate frameworks.Implement regulatory obligations into workflows, ensuring... ...will own key compliance workstreams and manage multi-faceted projects with long-term...Senior- OverviewWe are seeking a highly proactive Project Manager to support hardware-focused initiatives within a medical device R&D program. This role is critical to improving execution discipline across hardware deliverables, ensuring timelines, ownership, and milestones are...Medical device
- ...clinical evaluations for new product features and trials. The position emphasizes collaboration across regulatory, human factors, training, and product management, with a focus on translating clinical needs into validated, safe medical devices. #J-18808-Ljbffr Socket.devSeniorMedical device
- ...design controls and clinical risk assessment. You will participate in early design investigations, drive risk analysis, validation testing, and support clinical trials or launches while aligning with regulatory requirements. #J-18808-Ljbffr Intuitive Surgical, Inc. inSeniorMedical deviceFlexible hours
- ...Function of the PositionThe Senior Clinical Development Engineer... ...the surgical environment and medical technology to work with design... ...efficacy of new productsSupport regulatory documentation and submissions... ...of experience in medical device industry with a Bachelor’s degree...SeniorMedical deviceLocal areaWorldwideFlexible hours
- ...Senior Director of Strategic Alliances About the Company A contract development and manufacturing company serving medical device OEMs. Industry Medical Devices Type Privately Held... ..., executive-level relationship management, and the ability to work cross-...SeniorMedical deviceContract work
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