Regulatory Affairs Executive

Regulatory Affairs Executive Job Description Template

Our company is looking for a Regulatory Affairs Executive to join our team.


  • Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies;
  • Assist in clinical evaluation report for Medical devices;
  • Participate in regulatory team meetings and present project status updates;
  • Supporting the preparation of regulatory submissions for medicinal products, particularly GX, OTC and CCG;
  • provide launch readiness and other commercial project team support;
  • attend and participate in local and global meetings/calls as required, and present on regulatory topics when requested;
  • review and process all parallel import notifications received and liaise with the global patents department as required to respond to them;
  • Routine Management of the QMS CAPA plans;
  • Act as the QMS Management Representative;
  • Create and manage the international Declaration of Conformity;
  • Help ensure the management and update of product technical files;
  • Provide support in the global registration of products;
  • support EU strategy on specific projects on development/marketed products;
  • actively seek to minimize risks to the business, managing risks identified and alerting the Regulatory Affairs and Quality Manager;
  • monitor the status of competitor marketing authorisation’s as agreed with the local business.


  • A good understanding of MDD, ISO 13485 and QSR;
  • Degree in Science, Engineering or equivalent;
  • Some knowledge of EU regulatory requirements;
  • Minimum of two years’ experience in a similar position with experience of integrated QMS;
  • Good written and oral communication skills in English and French;
  • The role itself also present amazing opportunities to develop within the company whilst being surrounded by an amazing product portfolio;
  • This position is based in the beautiful French Riviera and so is perfect for anyone wishing to relocate.