Work Flexibility: Hybrid or Onsite 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: Switzerland: CHF108,500 - CHF181,000 CHF Annual 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% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.