Cluster Expert For Medical Device Regulatory Affairs And Vigilance

Fresenius Medical Care

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Medical device regulatory affairs expertise
Post-market surveillance and vigilance management
Local safety officer (lso) responsibilities
** Fresenius Medical Care is seeking a Cluster Expert for Medical Device Regulatory Affairs and Vigilance to oversee regulatory activities across an EMEA cluster. This role requires substantial experience in regulatory affairs within the MedTech/Pharma industries and emphasizes compliance, post-market surveillance, and stakeholder management. **

Job Summary

  • The role oversees all medical device regulatory activities across an assigned EMEA cluster to ensure timely market authorizations.
  • Candidates will manage post-market surveillance, vigilance activities, and Field Safety Corrective Actions while acting as a Local Safety Officer.
  • Fresenius Medical Care offers individual opportunities for self-determined career planning within a culture that values innovative thinking.

Matching Summary

Match Score: 75

** Fresenius Medical Care is seeking a Cluster Expert for Medical Device Regulatory Affairs and Vigilance to oversee regulatory activities across an EMEA cluster. This role requires substantial experience in regulatory affairs within the MedTech/Pharma industries and emphasizes compliance, post-market surveillance, and stakeholder management. **

Skills & Requirements

Must-have

  • Medical Device Regulatory Affairs expertise
  • Post-market surveillance and vigilance management
  • Local Safety Officer (LSO) responsibilities
  • EMEA cluster regulatory compliance oversight
  • MDR and GxP regulation knowledge

Nice-to-have

  • Cross-functional coordination at regional level
  • Continuous education in regulatory developments
  • Hungarian language skills as an asset

Key Requirements

  • 5-8 years experience in similar position
  • Bachelor's degree in Pharmacy, Life Sciences, or Chemistry
  • Minimum 5 years in MedTech regulatory submissions
  • Fluency in Slovak and Czech languages required
  • High proficiency in English written and spoken

Work Rights

Not specified

Tailored Resume

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