Clinical Affairs Specialist

Talents Solutions; Besançon; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

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.

Prestations

Environnement de travail stimulant

Opportunité de croître professionnellement

Équipe agile et soudée

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.

Responsabilités

• 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.

Connaissances

Analyse des données

Rédaction

Communication

Proactivité

Gestion du temps

Formation

Diplôme en sciences de la vie, ingénierie ou équivalent

Outils

MS Office

Outils de gestion de données

Description du poste

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