Medical Device RA Manager

Mission

Ensure compliance of products and services with regulatory requirements in all markets
Support product development teams with regulatory guidance, homologation plans and assessments
Evaluate impact on new regulations, standards and guidelines and lead their implementation
Ensure compliance of device technical files
Prepare regulatory documentation for product registration and submission to Notified Bodies and competent authorities in collaboration with external partners
Address regulatory requests from other departments, subsidiaries, distributors and customers
Raise awareness and train staff in regulatory topics relative to medical devices
Implement and execute post-marketing surveillance activities, including vigilance of medical devices

PROFIL

Bachelor or Master degree (scientific, Medical or Paramedical)
5 years experience in a similar position
Knowledge of medical device regulations FDA 21CFR 820, EU MDD, MDR
Excellent written and spoken level in English, and good spoken level in French

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