Work Flexibility: Remote
As a Senior Staff Regulatory Affairs Specialist (m/f/d) at Stryker, you will lead global regulatory strategies for innovative medical devices. Reporting to the Regulatory Affairs Manager, you'll support cross-functional teams, mentor colleagues, and ensure compliance across international markets, including the US and EU.
This position is limited to 30 June 2027.
What will you do:
1. Lead regulatory strategy for new products and changes, ensuring global compliance
2. Prepare and manage submissions (e.g., FDA, EU MDR, post-market reports)
3. Act as a liaison with regulatory authorities and notified bodies
4. Review and approve labeling, marketing, and change documentation
5. Support audits and inspections, providing expert regulatory guidance
6. Monitor regulatory trends and communicate updates internally
7. Mentor junior RA team members and support training activities
8. Contribute to process improvements and SOP development
What will you need:
9. Bachelor’s degree in life sciences, engineering, or related field
10. 5+ years of experience in medical device Regulatory Affairs
11. Strong knowledge of FDA, EU MDR, and global regulations
12. Proven experience with Class II/III medical device submissions
13. Excellent English communication skills
14. Master’s degree or Regulatory Affairs Certification (RAC)
15. Experience in orthopedics or implantable devices
16. German language skills
17. Familiarity with Quality Systems and Design Control
Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.
Additional information
Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence on site at our location in Kiel should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
Please note that the internal job title may differ from the ad title.
Travel Percentage: 10%