Senior Regulatory Affairs Specialist - Heart Recovery/abiomed

Johnson & Johnson

Aachen, North Rhine-Westphalia, Germany
Base: 75.000,00 eur to 118.450,00 eur; bonus/equit...
Hybrid
Eu medical device regulation (eu) 2017/745
Technical documentation / sted submissions
Change notifications
Prepare and review Notified Body applications and other regulatory documents including Technical Documentation / STED submissions, Change Notifications and Periodic Medical Device reports as assigned

Job Summary

  • Prepare and review Notified Body applications and other regulatory documents including Technical Documentation / STED submissions, Change Notifications and Periodic Medical Device reports as assigned.
  • Support regulatory planning and alignment with business and functional goals and priorities.
  • Present to Notified Bodies regulatory strategies and monitor changes of the regulatory landscape.

Matching Summary

Prepare and review Notified Body applications and other regulatory documents including Technical Documentation / STED submissions, Change Notifications and Periodic Medical Device reports as assigned.

Salary

Base: 75.000,00 EUR to 118.450,00 EUR; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • EU Medical Device Regulation (EU) 2017/745
  • Technical Documentation / STED submissions
  • Change Notifications
  • Periodic Medical Device reports
  • Manufacturing process compliance

Nice-to-have

  • Cardiovascular device experience
  • Medical Device software and hardware submissions
  • MDD to MDR transition experience
  • Independent judgment
  • Effective communication

Key Requirements

  • At least 5 years of regulatory affairs experience
  • Degree in Science, Engineering or IT
  • Fluent in English
  • Proficient in Microsoft Office Suite

Work Rights

Not specified

Tailored Resume

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