Regulatory Affairs Specialist

il y a 7 jours


Paris, Île-de-France Covartim 2021 Temps plein
Quality Assurance & Regulatory Affairs Manager

A key role in ensuring the compliance of medical devices with regulatory frameworks.

Key Responsibilities:
  • Implement Quality Management Systems at client sites, based on our developed framework.
  • Develop regulatory strategies for the introduction of innovative medical devices on the market.
  • Support clients in achieving compliance with regulatory requirements.
Requirements:
  • Good understanding of Medical Devices and IVD regulatory environment (directives, regulations).
  • Knowledge of Medical Devices quality assurance (ISO 13485, 21 CFR) and relevant standards.
  • Proficiency in French, Dutch, and English for communication with clients and team members.
What We Offer:
  • A comfortable and spacious office with green surroundings.
  • Meal vouchers (8 euros/day) and supplemental health insurance.
  • Complementary pension and public transport costs covered.
  • Training opportunities and well-being workshops.

We are looking for a skilled professional to join our team and contribute to the success of our clients in the medical device industry.


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