Clinical Affairs Specialist

Clinical Affairs Specialist Permanent Position Based in Besançon (25)

Company

Join a fast-growing and innovative French MedTech company specialized in the design, manufacturing, and regulatory approval of cutting-edge Class IIa medical devices. With a strong international presence, this company is recognized globally as a key player in the field of neurosurgery, endovascular surgery, and electrophysiology. Their flagship product is a market-leading intracerebral electrode used for diagnosing and treating drug-resistant epilepsy.

Opportunity

To support its regulatory and commercial growth, the company is currently looking for a Clinical Affairs Specialist. You will be part of a passionate and dynamic team, reporting directly to the Head of Quality & Regulatory Affairs. Your role will be key in ensuring clinical compliance and supporting the global market access of their innovative devices.

Responsibilities

• Contribute to the development of the companys clinical strategy

• Conduct literature reviews and synthesize scientific data

• Collect and analyze clinical data

• Coordinate post-market clinical follow-up (PMCF) activities

• Monitor and manage clinical studies

• Draft regulatory and clinical documents (protocols, clinical evaluation reports, PMCF plans/reports, etc.)

• Update and maintain SOPs related to regulatory and clinical activities

• Ensure scientific and regulatory watch

• Participate in risk management activities

Profile

• Degree in life sciences, engineering, or equivalent

• Minimum 2 years of experience in clinical affairs within the medical device industry

• Strong understanding of applicable regulations and standards (e.g., MDR, ISO 14155)

• Experience with bibliographic research, clinical evaluations, clinical investigations, and data analysis

• Background in a CRO or as a CRA is a plus

• Excellent writing, communication, and organizational skills

• Proactive, autonomous, and adaptable

• Fluent in English (written and spoken)

• Proficient in MS Office and data management tools

Why Join?

• Work for an innovative and internationally recognized MedTech leader

• Be part of a passionate, agile, and close-knit team

• Take responsibility in a strategic role influencing product safety and market success

• Develop your expertise in clinical affairs within cutting-edge medical technologies

• Enjoy a stimulating work environment where your ideas and autonomy are valued

• Opportunity to grow professionally in a company with ambitious development plans