Clinical Project Manager – Medical Devices
CT19
Paris
Clinical Affairs Manager – Medical Device Industry
We are seeking a highly skilled and experienced Clinical Affairs Manager to join our dynamic team! This role is ideal for a motivated professional with a strong background in clinical strategy, regulatory compliance, and project management.
Why Join Us?
- Work on innovative medical technologies that make a real impact.
- Join a dynamic and passionate team at the forefront of medical imaging advancements.
- Contribute to the development of next-generation MRI technology powered by quantum detection systems, making imaging more accessible and efficient.
- Be part of an organization that values collaboration, innovation, and professional growth.
Key Responsibilities
Planning and Management of Clinical Studies
- Define and execute the clinical strategy in accordance with regulatory requirements (US, EU).
- Design, plan, and oversee clinical investigations (pre- and post-marketing) in compliance with applicable regulations (ISO 14155, MDR 2017/745, GCP).
- Collaborate with cross-functional teams (Top Management, R&D, Regulatory Affairs, Quality Assurance) to align clinical activities with product development goals.
- Manage relationships with investigators, ethics committees, regulatory authorities, CROs, and other partners/service providers.
- Coordinate the selection of investigation centers.
- Monitor Post-Market Clinical Follow-up (PMCF) activities to ensure continuous compliance.
Clinical Documentation and Regulatory Compliance
- Lead the preparation, review, and submission of clinical documentation, including Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Investigator Brochure, clinical protocols, and other essential clinical documentation.
- Oversee the submission of clinical studies to regulatory agencies and ethics committees, ensuring compliance with U.S. and EU regulatory guidelines.
- Ensure all clinical documentation meets the highest standards of regulatory clarity, scientific accuracy, and quality.
- Ensure compliance with GDPR requirements regarding patient data management.
- Monitor and analyze clinical data in collaboration with medical and statistical teams.
Skills & Experience
- A Master’s degree or higher in life sciences, biomedical engineering, pharmacy, medicine, or health technology sciences.
- At least 3 years of experience in Clinical Affairs within the medical device industry.
- In-depth knowledge of applicable regulations (ISO 14155, MDR 2017/745, GCP).
- Strong project management skills with the ability to lead multiple projects simultaneously.
- Excellent writing, analytical, and synthesis skills.
- Bonus: Experience working in a startup environment.
Reach out to [email protected]