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Clinical Affairs Specialist
Job summary
Une entreprise MedTech française innovante recherche un Spécialiste des Affaires Cliniques pour soutenir sa croissance réglementaire et commerciale. Ce rôle est essentiel pour garantir la conformité clinique et favoriser l'accès au marché de dispositifs médicaux de pointe. Les candidats doivent avoir un diplôme en sciences de la vie et au moins 2 ans d'expérience dans le secteur des dispositifs médicaux, avec une connaissance des normes réglementaires.
Benefits
Qualifications
- Minimum 2 ans d'expérience en affaires cliniques dans l'industrie des dispositifs médicaux.
- Bonne compréhension des réglementations applicables (MDR, ISO 14155).
- Compétences organisationnelles et de communication solides.
Responsibilities
- Contribuer au développement de la stratégie clinique de l'entreprise.
- Rédiger des documents réglementaires et cliniques (protocoles, rapports d'évaluation clinique).
- Surveiller et gérer les études cliniques.
Skills
Education
Tools
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.
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
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
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