Senior Compliance Manager

il y a 2 semaines


Lyon, Auvergne-Rhône-Alpes, France Talents Solutions Temps plein
About the Role

We are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at Talents Solutions. As a key member of our MedTech company, you will be responsible for leading all regulatory activities in the EMEA region, ensuring compliance across innovative products throughout their lifecycle.

Key Responsibilities
  • Centralize, organize, and process regulatory requests as needed, and manage information accordingly.
  • Develop and maintain relevant instructions and procedures applicable to the activities and provide internal training.
  • Oversee onboarding and training of new team members and promote knowledge sharing.
Requirements
  • Degree qualified with minimum 7 year-experience in Regulatory Affairs positions in medical device industry including a mandatory experience in design / manufacturing (i.e. design control) and a thorough knowledge of risk management principles in accordance with EN ISO 14971.
  • Excellent knowledge of the regulatory and normative framework of Medical devices in Europe (MDD and MDR related).
  • Fluent in French and English (written and oral).
About Us

Talents Solutions is a leading MedTech company committed to innovation and excellence. We offer a supportive work environment with flex office options that promote a healthy work-life balance.



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