Analyst Medical Affairs (H/F)

La mission

Details of the mission: The Medical Affairs Analyst is responsible for leading and coordinating Medical Affairs activities that support the safety, performance, and regulatory compliance of medical devices throughout their lifecycle. This role serves as both a scientific contributor and project leader, driving cross-functional initiatives related to EU MDR compliance, Clinical Evaluation, Post-Market Surveillance, and product lifecycle management. The position requires effective project management of MDR-related deliverables, coordination of global stakeholders, and leadership of programs aimed at maintaining regulatory compliance and continuous improvement of Medical Affairs processes. Role and responsibilities: • Provide medical and scientific support for assigned medical device portfolios throughout the product lifecycle. • Conduct literature reviews, clinical data assessments, and state-of-the-art evaluations. • Develop and maintain CEPs, CERs, and related clinical evidence documentation. • Coordinate EU MDR clinical, PMS, PMCF, and PSUR deliverables across product families. • Evaluate complaints, vigilance data, literature, and emerging safety signals to support risk and benefit-risk assessments. • Support regulatory submissions, product lifecycle activities, audits, and interactions with Notified Bodies and Competent Authorities. • Collaborate with Regulatory, Quality, R&D, Clinical, Risk Management, Toxicology, Biocompatibility, and Vigilance teams. • Manage project plans, timelines, dependencies, risks, metrics, and stakeholder updates. • Monitor regulatory and standards developments and contribute to process improvement and team knowledge-sharing. Benefits to join your team: • Gain hands-on experience in global Medical Affairs and EU MDR activities across the medical device lifecycle. • Work on meaningful projects that support patient safety, product performance, and regulatory compliance. • Collaborate with experienced, cross-functional, and international teams. • Build expertise in clinical evidence, post-market surveillance, risk management, and regulatory strategy. • Develop project management, stakeholder engagement, and professional communication skills in a supportive team environment.