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Spécialiste Affaires Règlementaires – F/H

Présentation société

Bienvenue chez TALENTS SOLUTIONS, votre partenaire privilégié pour le recrutement spécialisé dans le domaine du RAQA (Assurance Qualité et Affaires Réglementaires) de l’industrie des dispositifs médicaux en France.

Dirigée par Monia Tazamoucht, une professionnelle chevronnée avec plus de 6 ans d’expérience dans le domaine, TALENTS SOLUTIONS s’engage à fournir des solutions de recrutement sur mesure qui répondent aux besoins spécifiques de votre entreprise.

Chez TALENTS SOLUTIONS, nous comprenons l’importance cruciale de chaque recrutement pour votre entreprise. C’est pourquoi nous mettons un accent particulier sur la qualité, la précision et la rapidité dans la sélection des candidats. Notre approche personnalisée garantit que nous trouvons les profils qui correspondent non seulement aux compétences techniques requises, mais aussi à la culture et aux valeurs de votre entreprise.

Nous nous engageons à établir des partenariats solides et durables avec nos clients, en leur offrant un service de recrutement fiable, transparent et axé sur les résultats.

THE COMPANY

The company is an innovative MedTech manufacturer developing next-generation medical devices addressing critical unmet clinical needs.

The company operates in a highly technical and regulated environment, combining advanced engineering, software technologies (SaMD), and strong clinical expertise.

It is currently entering a key clinical investigation phase, making Regulatory Affairs a central pillar of its development strategy.

Regulatory, Clinical, R&D and Quality teams work in close collaboration throughout the full product lifecycle, from design and clinical investigation to CE marking and market access under EU MDR.

This is a growing organization with strong European ambitions, offering a hands-on environment where regulatory decisions have a direct impact on product strategy and patient outcomes.

THE OPPORTUNITY

We are recruiting a Regulatory Affairs Specialist to join an innovative MedTech company developing highly complex medical devices, currently in a clinical investigation phase.

This is a strategic RA position with strong exposure to EU MDR, CE marking, clinical activities, and Software as a Medical Device (SaMD).

Ideal for a regulatory professional looking for technical depth, ownership, and real project impact.

RESPONSIBILITIES

As Regulatory Affairs Specialist, you will:

• Monitor regulatory and standards evolution and ensure integration into development programs and the Quality Management System
• Review R&D and manufacturing evidence to ensure compliance with regulatory and normative requirements
• Prepare and coordinate regulatory documentation, including:
  GSPR
  Technical Documentation
  Declarations of Conformity
  CE marking and other market submission files
• Manage submissions to authorities and notified bodies, including Q&A coordination
• Support clinical investigation activities (Investigator Brochures, user information documents, authority interactions)
• Lead clinical evaluation activities and post-market clinical follow-up
• Ensure post-market surveillance (PMS) and vigilance activities
• Handle administrative registrations (ANSM, EUDAMED, etc.)
• Contribute to the development and continuous improvement of Regulatory Affairs processes within the QMS

Descriptif du profil

REQUIREMENTS

You bring:

• Solid experience with EU MDR 2017/745
• Strong understanding of notified body expectations and regulatory interpretations
• Experience in medical device development environments
• Excellent writing skills and strong documentary rigor
• Fluency in English (written and spoken)
• A practical, solution-oriented mindset and ability to work cross-functionally
• Knowledge of FDA or other international registrations is a plus

Postuler

Monia
monia@talentssolutions.fr