Clinical Affairs Specialist
Clinical Affairs Specialist
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Job Description
Clinical Affairs Specialist Permanent Position Based in Besanon (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
Employment Type
Full Time
