Regulatory Affairs Manager - Product Development

  • Regulatory affairs|Product Development
  • Company

    Our client is an international company specialized in medical devices.


    • Regulatory support to Clinical development and to new product development
    • Coordinate the preparation and participate to meetings with Health Authorities and Notified Bodies prior to regulatory submissions
    • Monitor actively the Regulatory Intelligence process by ensuring evaluation of new regulations and guidelines and leading their implementation
    • Ensure RA excellence (support the establishment, maintenance and optimization of
      Regulatory Affairs processes and procedures)
    • Ensure effective communication across the global Regulatory Affairs team


    • 8 years of regulatory affairs experience in the medical device industry (Class III medical device knowledge would be ideal)
    • Experience in people management
    • Knowledge of European and US medical device regulations
    • Experience with clinical trial regulations, as well as with product development and design control processes


    Great opportunity to join an international company, build a team from scratch and play a key role in the development of new innovative products.

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