Job details
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:
Lead regulatory strategy for new products and changes, ensuring global compliance
Prepare and manage submissions (e.g., FDA, EU MDR, post-market reports)
Act as a liaison with regulatory authorities and notified bodies
Review and approve labeling, marketing, and change documentation
Support audits and inspections, providing expert regulatory guidance
Monitor regulatory trends and communicate updates internally
Mentor junior RA team members and support training activities
Contribute to process improvements and SOP development
What will you need:
Required:
Bachelor’s degree in life sciences, engineering, or related field
5+ years of experience in medical device Regulatory Affairs
Strong knowledge of FDA, EU MDR, and global regulations
Proven experience with Class II/III medical device submissions
Excellent English communication skills
Preferred:
Master’s degree or Regulatory Affairs Certification (RAC)
Experience in orthopedics or implantable devices
German language skills
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.
