As a Senior Staff Regulatory Affairs Specialist at Stryker, you will lead global regulatory strategies for innovative medical devices and ensure compliance across international markets
Job Summary
As a Senior Staff Regulatory Affairs Specialist at Stryker, you will lead global regulatory strategies for innovative medical devices and ensure compliance across international markets.
This position offers flexible working hours with partial remote work, but requires regular presence at the Kiel location to maintain personal contact with colleagues and departments.
You will mentor junior RA team members, support training activities, and contribute to process improvements and SOP development.
Matching Summary
As a Senior Staff Regulatory Affairs Specialist at Stryker, you will lead global regulatory strategies for innovative medical devices and ensure compliance across international markets.
Skills & Requirements
Must-have
Global regulatory compliance
Medical device submissions
FDA and EU MDR knowledge
Regulatory strategy leadership
Cross-functional team support
Regulatory audits and inspections
Nice-to-have
Mentoring junior team members
Process improvement contributions
Orthopedics or implantable devices experience
German language skills
Familiarity with Quality Systems and Design Control
Key Requirements
Bachelor’s degree in life sciences or engineering
5+ years medical device Regulatory Affairs experience
Proven Class II/III medical device submission experience