Requirements: English
Company: Barrington James
Region: Dijon , Bourgogne-Franche-Comt
Join a fast-growing leader in the sports medicineindustry! We''re looking for a proactive and detail-orientedClinical Affairs Officer to help drive innovation and ensure thesafety and performance of our products. As part of our dynamicR&D team, you''ll play a key role in clinical studies,regulatory compliance, and competitive intelligence. KeyResponsibilities: - Research & Analysis: Stay on top ofclinical and scientific literature, analyzing competitor productsfor safety, efficacy, and performance. - Clinical Safety: Draft andmanage Clinical Evaluation Reports (CER), Post-Market ClinicalFollow-Up (PMCF) studies, and support post-market surveillance(PMS). - Clinical Studies: Write study documentation, implementprotocols, monitor product safety in clinical settings, andcollaborate with CROs to manage studies effectively. - RegulatorySupport: Assist in product registration globally and contribute todrafting essential regulatory documents such as CER and ClinicalDevelopment Plans (CDP). Qualifications: - Biomedical degree orrelated field with at least 2 years of experience in clinical andregulatory affairs, ideally in medical devices or diagnosticsoftware. - Strong knowledge of medical device regulations(MDD/MDR, ISO 14971, ISO 13485). - Proficient in draftingregulatory documents like CER, PMCF, PSUR. - Excellent Englishcommunication skills (written and editorial). - Highly organized,autonomous, and able to work under pressure. Why Join Us? This isan exciting opportunity to shape the future of sports medicine,working with cutting-edge technologies in a collaborative anddynamic environment. If you''re passionate about healthcareinnovation and eager to make an impact, we want to hear fromyou!