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 (3 days onsite in aachen)
European medical device regulation (eu) 2017/745
Prepare and review notified body applications
Technical documentation / sted submissions
Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist for its Abiomed division, focusing on regulatory submissions for cardiovascular medical devices in compliance with European regulations. The role requires significant experience in regulatory affairs, particularly within the medical device sector, and offers an inclusive and collaborative work environment

Job Summary

  • As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.
  • Your talents will help to bring Impella heart pumps to more patients globally.
  • Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist for its Abiomed division, focusing on regulatory submissions for cardiovascular medical devices in compliance with European regulations. The role requires significant experience in regulatory affairs, particularly within the medical device sector, and offers an inclusive and collaborative work environment.

Salary

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

Skills & Requirements

Must-have

  • European Medical Device Regulation (EU) 2017/745
  • Prepare and review Notified Body applications
  • Technical Documentation / STED submissions
  • Communicate regulatory project status

Nice-to-have

  • Support submissions to countries oriented towards CE marking
  • Provide regulatory guidance to project teams
  • Inclusive work environment
  • Continuous development

Key Requirements

  • At least 5 years of regulatory affairs experience
  • Degree in Science, Engineering or IT
  • Fluent in English
  • Experience with EU 2017/745 submissions

Work Rights

Not specified

Tailored Resume

Cover Letter