Analyst Medical Affairs (H/F)

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.

Required skills: scientific and clinical literature review; critical appraisal and interpretation of clinical and post-market data; understanding of EU MDR, clinical evaluation, PMS, PMCF, PSUR, vigilance, and risk management; strong analytical and technical writing skills; project management and organizational skills; effective communication and stakeholder management; ability to collaborate in international, cross-functional teams; attention to detail and ability to manage multiple priorities; proficiency in Microsoft Office; fluent written and spoken English.

Baxter is more than a company. It is a community of committed professionals. Every year, our products reach more than 60 million patients worldwide. Baxter has a diverse group of employees in more than 100 countries who share a passion for saving and sustaining lives. Whether you join us for few years or your entire career, we are united to advancing modern healthcare. Fostering collaborative innovation, continuous learning and diversity are part of our DNA. If you eager to grow in a stimulating, caring environment and look for a daily basis purpose, we are the place to be! During your assignment with us, you will benefit from the presence of a large community of well-established VIEs, as well as numerous activities and benefits.