Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)
Stryker · Mahwah, NJ
RegulatoryFull-time$78k–$130kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Staff Regulatory Affairs Specialist role supporting Stryker's robotics and enabling technologies portfolio. Provides regulatory leadership across the product lifecycle, managing global submissions, compliance activities, and cross-functional partnerships for U.S. and international markets. Remote position.
What they're looking for
- Bachelor's degree in Engineering, Sciences, Regulatory Affairs, or related field
- Minimum 4 years experience in FDA-regulated industry
- Minimum 3 years regulatory affairs experience
- Experience preparing regulatory submissions for product approvals
- Regulatory Affairs Certification (RAC) preferred
- Experience with Class II or III medical devices preferred
What you'll be doing
- Develop and execute global regulatory strategies for new products and lifecycle management activities
- Prepare and submit FDA and international regulatory filings with supporting documentation
- Evaluate product classifications, pathways, and jurisdictional requirements across markets
- Lead interactions with regulatory authorities and notified bodies on submissions and communications
- Review labeling, marketing materials, and clinical documentation for regulatory compliance
Privacy & handoff
This role links to Stryker's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.