Clinical Affairs Officer

Barrington James; Dijon; Sur place; EUR 20 000 - 40 000; Plein temps

Résumé du poste

An established industry player in sports medicine is seeking a Clinical Affairs Officer to join their innovative R&D team. In this pivotal role, you will be responsible for driving clinical studies, ensuring regulatory compliance, and analyzing competitor products. This exciting opportunity allows you to work with cutting-edge technologies and contribute to the future of healthcare. If you are passionate about making an impact in the medical field and thrive in a collaborative environment, this position is perfect for you. Join us and help shape the future of sports medicine!

Qualifications

• 2+ years in clinical and regulatory affairs, ideally in medical devices.
• Strong knowledge of medical device regulations and drafting regulatory documents.

Responsabilités

• Conduct research and analysis on clinical literature and competitor products.
• Draft and manage Clinical Evaluation Reports and support post-market surveillance.

Connaissances

Clinical Affairs

Regulatory Compliance

Research & Analysis

Communication Skills

Organizational Skills

Formation

Biomedical degree

Outils

ISO 14971

ISO 13485

Description du poste

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!