Cluster Lead For Medical Device Regulatory Affairs And Vigilance

Fresenius Medical Care

Not specified; competitive salary offered; benefit...
Not specified
Medical device regulatory submissions
Emea cluster leadership experience
Post-market surveillance and vigilance
Fresenius Medical Care is seeking a Cluster Lead for Medical Device Regulatory Affairs and Vigilance to oversee regulatory activities across an EMEA cluster, ensuring compliance and market authorizations. The ideal candidate will have extensive experience in regulatory affairs within the pharma/biotech/medical devices sector, alongside leadership experience and strong knowledge of regulatory frameworks

Job Summary

  • The role oversees all medical device regulatory activities across an assigned EMEA cluster ensuring timely compliant market authorizations.
  • Fresenius Medical Care is the global leader in kidney care committed to improving lives with over 125,000 employees worldwide.
  • Candidates receive a competitive salary alongside benefits including 33 days holiday, company pension scheme, and health cash plans.

Matching Summary

Match Score: 85

Fresenius Medical Care is seeking a Cluster Lead for Medical Device Regulatory Affairs and Vigilance to oversee regulatory activities across an EMEA cluster, ensuring compliance and market authorizations. The ideal candidate will have extensive experience in regulatory affairs within the pharma/biotech/medical devices sector, alongside leadership experience and strong knowledge of regulatory frameworks.

Salary

Not specified; Competitive salary offered; Benefits include pension, life assurance, 33 days holiday, health cash plan

Skills & Requirements

Must-have

  • Medical device regulatory submissions
  • EMEA cluster leadership experience
  • Post-market surveillance and vigilance
  • UK MDR and EU MDR compliance knowledge
  • ISO 13485 and GxP standards expertise

Nice-to-have

  • Strong stakeholder management skills
  • Cross-functional team collaboration
  • Innovative thinking in healthcare
  • Willingness to travel within EMEA

Key Requirements

  • Degree in natural science field
  • 5-8 years regulatory affairs experience
  • 3+ years leadership experience in MedTech
  • Experience with UK and EMEA authorities
  • High proficiency in English and local language

Work Rights

Not specified

Tailored Resume

Cover Letter