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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.
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.
Switzerland Pay Ranges:
At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package.
If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process.
Travel Percentage: 10%
