Senior Staff Regulatory Affairs (m/f/d)

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:

• 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. 

Travel Percentage: 10%