Talent Job Seeker
Clinical Affairs Specialist
- directions_car Besançon
- work Full-time
About the position
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
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Contribute to the development of the companys clinical strategy
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Conduct literature reviews and synthesize scientific data
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Collect and analyze clinical data
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Coordinate post-market clinical follow-up (PMCF) activities
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Monitor and manage clinical studies
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Draft regulatory and clinical documents (protocols, clinical evaluation reports, PMCF plans/reports, etc.)
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Update and maintain SOPs related to regulatory and clinical activities
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Ensure scientific and regulatory watch
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Participate in risk management activities
Profile
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Degree in life sciences, engineering, or equivalent
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Minimum 2 years of experience in clinical affairs within the medical device industry
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Strong understanding of applicable regulations and standards (e.g., MDR, ISO 14155)
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Experience with bibliographic research, clinical evaluations, clinical investigations, and data analysis
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Background in a CRO or as a CRA is a plus
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Excellent writing, communication, and organizational skills
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Proactive, autonomous, and adaptable
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Fluent in English (written and spoken)
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Proficient in MS Office and data management tools
Why Join?
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Work for an innovative and internationally recognized MedTech leader
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Be part of a passionate, agile, and close-knit team
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Take responsibility in a strategic role influencing product safety and market success
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Develop your expertise in clinical affairs within cutting-edge medical technologies
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Enjoy a stimulating work environment where your ideas and autonomy are valued
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Opportunity to grow professionally in a company with ambitious development plans
Place of work
Besançon
app.general.countries.France
About the company
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Relevant places near
- Besançon
- Saint-Vit
- Ornans
- Thise
- Saône
- École-Valentin
- Miserey-Salines
- Roche-lez-Beaupré
- Avanne-Aveney
- Montferrand-le-Château
Job ID: 9717908
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