Clinical Affairs Officer

Barrington James is seeking a Clinical Affairs Officer to join an innovative and fast-growing medical device organisation. This role offers the opportunity to take ownership of clinical and regulatory activities, making a real impact in the healthcare industry Key Responsibilities: Conduct scientific and competitive intelligence , including literature reviews, analysis of competitor products, and maintaining a bibliographic repository. Develop and manage clinical safety documents , such as Clinical Evaluation Reports (CER) and Post-Market Clinical Follow-up (PMCF) studies. Take ownership of clinical studies by designing protocols, managing collaborations with CROs, and analysing results. Support the regulatory affairs team with product registrations and drafting essential clinical reports. What We’re Looking For: A biomedical engineering or health/biomedical graduate with at least 2 years of experience in clinical and regulatory affairs for medical devices. Expertise in drafting key documents (CER, PMCF, PSUR) and knowledge of medical device regulations (MDD/MDR, ISO 14971, ISO 13485). Strong bibliographic research and analytical skills, with professional-level English writing ability. A self-motivated, detail-oriented individual with a curious mindset and excellent communication skills. This is a unique opportunity to take full ownership of clinical and regulatory functions within a forward-thinking organisation. You’ll work with cutting-edge technologies and have a meaningful impact on advancing healthcare. To apply: kwilsonbarringtonjames.com Direct line: 44 1293 223 951

Location: Dijon, FR

Posted Date: 2/4/2025