Work Flexibility: Hybrid or Onsite
As a Senior Staff Specialist, Regulatory Affairs (m/f/d), you will serve as a technical expert and strategic advisor within Stryker’s regulatory organization. You will drive regulatory strategy across the product lifecycle and partner closely with cross-functional teams to ensure our medical technologies meet global regulatory and legal requirements. In this highly specialized role, you will provide deep expertise, influence key decisions, and help shape successful pathways for global market access.
What You Will Do
1. Develop and evolve regulatory strategies by assessing regulatory intelligence, emerging trends, and changes in global requirements.
2. Advise R&D, Quality, Clinical, and Marketing teams throughout the product lifecycle to ensure regulatory compliance, appropriate product claims, and strong submission readiness.
3. Evaluate product concepts, classifications, and regulatory pathways to identify opportunities, risks, and solutions for timely market access.
4. Negotiate with regulatory authorities and lead interactions throughout product development, submission, and review.
5. Prepare, submit, and track global regulatory submissions in alignment with regulatory guidelines and internal quality standards.
6. Assess the impact of proposed clinical, manufacturing, or product changes and recommend regulatory filing strategies.
7. Support the development and implementation of new or updated SOPs, processes, and guidance documents to ensure compliance.
8. Train and mentor stakeholders on regulatory requirements, expectations, and best practices to enhance organizational capability.
What You Will Need
9. Bachelor’s degree in Engineering, Life Sciences, or a related field.
10. Minimum 6 years of regulatory affairs experience in medical devices or another highly regulated industry.
11. Strong knowledge of global regulatory pathways, submission requirements, and product lifecycle management.
12. Experience developing regulatory strategies and interacting with regulatory authorities.
13. Ability to analyze complex information, exercise sound judgment, and propose actionable solutions.
14. Strong communication, collaboration, and stakeholder-influencing skills.
15. Ability to manage multiple priorities and operate independently with sound decision-making.
16. Master’s degree in Regulatory Science or related field.
17. Regulatory Affairs Certification (RAC).
18. Experience supporting premarket submissions, post-market activities, and global registrations.
19. Familiarity with clinical investigations, pre-approval inspections, and postmarketing surveillance.
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
The position is initially limited for 12 months (with a possibility of an extension). Due to the large number of different positions and areas of responsibility, Stryker often offers the options of being taken on in a permanent position.
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 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%