Manager, Regulatory Affairs Emea

PPD (Thermo Fisher) UK

Multiple Locations
Eu regulatory compliance
Post-market surveillance
Vigilance reporting
The Manager, Regulatory Affairs – EMEA is responsible for leading regulatory activities for the LSG IVD and/or MD medical device portfolio

Job Summary

  • The Manager, Regulatory Affairs – EMEA is responsible for leading regulatory activities for the LSG IVD and/or MD medical device portfolio.
  • This role ensures compliance with applicable EU regulations and is accountable for EU product registrations.
  • The position partners cross-functionally to support product lifecycle management and sustainable market access across the EMEA region.

Matching Summary

The Manager, Regulatory Affairs – EMEA is responsible for leading regulatory activities for the LSG IVD and/or MD medical device portfolio.

Skills & Requirements

Must-have

  • EU regulatory compliance
  • Post-Market Surveillance
  • Vigilance reporting

Nice-to-have

  • Experience with cross-functional teams
  • Strong project management skills
  • Ability to work independently

Key Requirements

  • Bachelor’s degree in Life Sciences
  • Minimum 8 years of experience in Regulatory Affairs
  • Strong knowledge of EU IVDR and MDR regulations

Work Rights

Not specified

Tailored Resume

Cover Letter