Clinical Affairs Officer

Join a fast-growing leader in the sports medicine industry! We're looking for a proactive and detail-oriented Clinical Affairs Officer to help drive innovation and ensure the safety and performance of our products. As part of our dynamic R&D team, you'll play a key role in clinical studies, regulatory compliance, and competitive intelligence. Key Responsibilities: Research & Analysis: Stay on top of clinical and scientific literature, analyzing competitor products for safety, efficacy, and performance. Clinical Safety: Draft and manage Clinical Evaluation Reports (CER), Post-Market Clinical Follow-Up (PMCF) studies, and support post-market surveillance (PMS). Clinical Studies: Write study documentation, implement protocols, monitor product safety in clinical settings, and collaborate with CROs to manage studies effectively. Regulatory Support: Assist in product registration globally and contribute to drafting essential regulatory documents such as CER and Clinical Development Plans (CDP). Qualifications: Biomedical degree or related field with at least 2 years of experience in clinical and regulatory affairs, ideally in medical devices or diagnostic software. Strong knowledge of medical device regulations (MDD/MDR, ISO 14971, ISO 13485). Proficient in drafting regulatory documents like CER, PMCF, PSUR. Excellent English communication skills (written and editorial). Highly organized, autonomous, and able to work under pressure. Why Join Us? This is an exciting opportunity to shape the future of sports medicine, working with cutting-edge technologies in a collaborative and dynamic environment. If you're passionate about healthcare innovation and eager to make an impact, we want to hear from you!

Location: Dijon, FR

Posted Date: 5/9/2025