Senior Staff Regulatory Affairs (m/f/d)

Work Flexibility: Remote<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p>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&#39;ll support cross-functional teams, mentor colleagues, and ensure compliance across international markets, including the US and EU.</p><p></p><p>This position is limited to<b> 30 June 2027.</b></p><p></p><p><b>What will you do:</b></p><ul><li><p><span>Lead regulatory strategy for new products and changes, ensuring global compliance</span></p></li><li><p>Prepare and manage submissions (e.g., FDA, EU MDR, post-market reports)</p></li><li><p>Act as a liaison with regulatory authorities and notified bodies</p></li><li><p>Review and approve labeling, marketing, and change documentation</p></li><li><p>Support audits and inspections, providing expert regulatory guidance</p></li><li><p>Monitor regulatory trends and communicate updates internally</p></li><li><p>Mentor junior RA team members and support training activities</p></li><li><p>Contribute to process improvements and SOP development</p></li></ul><p></p><p><b>What will you need:</b></p><p><i>Required:</i></p><ul><li><p>Bachelor’s degree in life sciences, engineering, or related field</p></li><li><p>5&#43; years of experience in medical device Regulatory Affairs</p></li><li><p>Strong knowledge of FDA, EU MDR, and global regulations</p></li><li><p>Proven experience with Class II/III medical device submissions</p></li><li><p>Excellent English communication skills</p></li></ul><p></p><p><i>Preferred:</i></p><ul><li><p>Master’s degree or Regulatory Affairs Certification (RAC)</p></li><li><p>Experience in orthopedics or implantable devices</p></li><li><p>German language skills</p></li><li><p>Familiarity with Quality Systems and Design Control</p></li></ul><p></p><p>Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity. </p><p></p><p><b>Additional information</b> </p><p>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.</p><p>  </p><p>Please note that the internal job title may differ from the ad title. </p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>Travel Percentage: 10%<p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p></p><p></p><p></p><p></p>