Clinical Affairs Officer

JR France; Nantes; Sur place; EUR 40 000 - 55 000; Plein temps

Résumé du poste

Join a leading company in sports medicine as a Clinical Affairs Officer. You will play a vital role in driving innovation, ensuring product safety, and managing clinical studies. This position offers a chance to work with cutting-edge technologies in a dynamic environment.

Qualifications

• At least 2 years of experience in clinical and regulatory affairs.
• Strong knowledge of medical device regulations.

Responsabilités

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

Connaissances

Communication

Research & Analysis

Regulatory Knowledge

Organizational Skills

Formation

Biomedical degree

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:

1. Research & Analysis: Stay on top of clinical and scientific literature, analyzing competitor products for safety, efficacy, and performance.
2. Clinical Safety: Draft and manage Clinical Evaluation Reports (CER), Post-Market Clinical Follow-Up (PMCF) studies, and support post-market surveillance (PMS).
3. Clinical Studies: Write study documentation, implement protocols, monitor product safety in clinical settings, and collaborate with CROs to manage studies effectively.
4. 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!