Cluster Lead, Medical Device Pre & Post Market Surveillance

Fresenius Medical Care

EMEA
Medical device regulatory affairs
Post-market surveillance
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.
  • Responsibilities include leading and developing a regulatory team, managing regulatory submissions, registrations, renewals, and variations, and serving as the main regulatory contact for authorities.
  • The company offers 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 affairs
  • Post-market surveillance
  • Regulatory strategy development
  • Regulatory authority liaison
  • EMEA regulatory compliance

Nice-to-have

  • Innovative thinking
  • Team development
  • Continuous improvement
  • Global corporation benefits

Key Requirements

  • 5-8 years regulatory affairs experience
  • 3+ years leadership experience
  • Degree in natural science field
  • Experience with UK MDR, EU MDR
  • Proficiency in English and local language

Work Rights

Not specified

Tailored Resume

Cover Letter