International Regulatory Affairs Specialist

About the role

Stryker is hiring an International Regulatory Affairs Specialist in Irvine, CA, to ensure global product registrations move efficiently and compliantly through diverse regulatory pathways. The role drives operational excellence, collaborates across global teams and helps deliver safe, effective products to patients internationally. Work flexibility is hybrid, and candidates must live within commuting distance of Irvine and be able to work onsite several days per week.

Key responsibilities

• Evaluate products, product changes and manufacturing changes to determine regulatory classification, jurisdiction, submission requirements and approval pathways.
• Assess regulatory intelligence and evolving regulations to support local, regional and global regulatory strategies.
• Advise cross-functional teams on regulatory requirements throughout the product lifecycle, from concept and development to manufacturing, labeling and commercialization.
• Identify regulatory risks, obstacles and market access considerations, and develop compliant regulatory solutions and action plans.
• Prepare, compile and submit regulatory filings and notifications electronically and on paper, according to regulations and timelines.
• Monitor regulatory authority reviews, communicate with agencies and support meetings, inspections, advisory committees and other regulatory interactions.
• Build and maintain relationships with global regulatory and cross-functional partners to support registration needs.
• Review quality, preclinical, clinical and manufacturing documentation for submission readiness and compliance.
• Develop and update internal monitoring and metric systems to optimize regulatory submission planning.

Required profile

• Bachelor's degree in Engineering, Life Sciences, Regulatory Science or a related discipline.
• Minimum 4 years of regulatory affairs experience in the medical device, biotechnology, pharmaceutical or related regulated industry.
• Experience preparing and supporting international regulatory submissions and regulatory compliance activities.
• Experience interpreting and applying regional and global regulatory requirements across product development and lifecycle management.
• Preferred: Master's degree in Regulatory Science or a related scientific discipline; Regulatory Affairs Certification (RAC); experience supporting interactions with regulatory authorities and inspections; experience supporting clinical, preclinical, quality or manufacturing activities.