Senior Regulatory Affairs Specialist - Heart Recovery/abiomed

Johnson & Johnson / Abiomed

Aachen, North Rhine-Westphalia, Germany
Base: 75,000.00 eur to 118,450.00 eur; bonus/equit...
Hybrid
Eu medical device regulation 2017/745 experience
Notified body application preparation
Technical documentation review
This role involves preparing and reviewing Notified Body applications and technical documentation for cardiovascular devices under EU regulations

Job Summary

  • This role involves preparing and reviewing Notified Body applications and technical documentation for cardiovascular devices under EU regulations.
  • The position supports the global expansion of Impella heart pumps by ensuring regulatory compliance across Europe and other jurisdictions.
  • Candidates will work with a hybrid schedule requiring three days on-site in Aachen while collaborating with engineering teams on product development.

Matching Summary

This role involves preparing and reviewing Notified Body applications and technical documentation for cardiovascular devices under EU regulations.

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 2017/745 experience
  • Notified Body application preparation
  • Technical documentation review
  • Manufacturing process compliance
  • Cardiovascular device background

Nice-to-have

  • German language proficiency
  • Software and hardware submission experience
  • MDD to MDR transfer experience
  • Independent judgment in evaluation
  • Collaborative team environment

Key Requirements

  • Degree in Science, Engineering or IT
  • At least 5 years of regulatory affairs experience
  • Proven track record in EU MDR submissions

Work Rights

Not specified

Tailored Resume

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