Requirements: English
Company: Barrington James
Region: Dijon , Bourgogne-Franche-Comt
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!