Senior Regulatory Affairs Specialist - Heart Recovery/abiomed

Johnson & Johnson

Aachen, North Rhine-Westphalia, Germany
Base: 75.000,00 eur - 118.450,00 eur; bonus/equity...
Hybrid
Eu medical device regulation (eu) 2017/745
Technical documentation / sted submissions
Change notifications
Prepare and review submissions in accordance with the European Medical Device Regulation (EU) 2017/745

Job Summary

  • Prepare and review submissions in accordance with the European Medical Device Regulation (EU) 2017/745.
  • Support submissions to countries oriented towards CE marking and provide regulatory guidance to project teams.
  • Develop and implement regulatory strategies throughout the product lifecycle that are consistent with business unit goals and objectives.

Matching Summary

Prepare and review submissions in accordance with the European Medical Device Regulation (EU) 2017/745.

Salary

Base: 75.000,00 EUR - 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
  • Product development guidance
  • Regulatory landscape monitoring

Nice-to-have

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter