Senior Manager, Regulatory Affairs
Stryker · Irvine, CA
RegulatoryFull-time$167k–$279kCompany career page
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Role summary
Senior Manager overseeing global regulatory strategy and compliance for the Peripheral Vascular division's product portfolio. Leads regulatory operations, manages submissions and compliance activities, and develops a high-performing regulatory team across the full product lifecycle.
What they're looking for
- Bachelor's degree required
- 10+ years in regulated environments with expertise in U.S. and international regulatory requirements
- 3+ years of demonstrated people leadership experience including talent development and performance management
- Experience analyzing regulatory data, trends, and performance metrics for compliance and risk management
- Medical device industry experience with FDA regulations and quality requirements (preferred)
- Experience with FDA 510(k) and/or EU MDR submissions (preferred)
- Project management experience with planning, execution, and cross-functional coordination (preferred)
What you'll be doing
- Support global regulatory strategy across full product lifecycle from development through post-market and obsolescence
- Provide regulatory guidance on product claims, labeling, instructions for use, and patient materials
- Assess regulatory impact and requirements for product, manufacturing, supplier, and clinical changes
- Lead regulatory operations including submissions, compliance programs, audits, and authority interactions
- Build and lead high-performing Regulatory Affairs team through talent development and resource planning
Privacy & handoff
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