Cluster Lead For Medical Device Regulatory Affairs And Vigilance

Fresenius Medical Care

Medical device regulatory activities
Product lifecycle regulatory expertise
Regulatory strategy development
The Cluster Lead oversees all medical device regulatory activities across an assigned EMEA cluster, ensuring timely, compliant market authorisations and ongoing product availability

Job Summary

  • The Cluster Lead oversees all medical device regulatory activities across an assigned EMEA cluster, ensuring timely, compliant market authorisations and ongoing product availability.
  • Your Responsibilities include leading and developing a regulatory team, managing regulatory submissions, registrations, renewals, and variations for medical devices across assigned countries.
  • Our Offer For You includes individual opportunities for self-determined career planning and professional development within a corporate culture that encourages innovative thinking.

Matching Summary

The Cluster Lead oversees all medical device regulatory activities across an assigned EMEA cluster, ensuring timely, compliant market authorisations and ongoing product availability.

Skills & Requirements

Must-have

  • Medical device regulatory activities
  • Product lifecycle regulatory expertise
  • Regulatory strategy development
  • Liaise with regulatory authorities
  • Post-market surveillance activities
  • Manage regulatory risks

Nice-to-have

  • Improve patient outcomes
  • Drive transformation through innovation
  • Continuous improvement and system harmonization
  • Compassionate team environment

Key Requirements

  • Degree in a natural science field
  • 5-8 years regulatory affairs experience
  • 5-8 years working across multiple countries
  • 3+ years of leadership experience
  • Experience with UK MDR, EU MDR, FDA regulations
  • Experience with UK and EMEA regional requirements
  • Knowledge of ISO 9001, ISO 13485, GxP

Work Rights

Not specified

Tailored Resume

Cover Letter