Staff International Regulatory Affairs Specialist
Stryker
Summary
In this International Regulatory Affairs role, you will ensure global product registrations move efficiently and compliantly through diverse regulatory pathways. This is a meaningful opportunity to drive operational excellence, collaborate across global teams, and directly influence our ability to deliver safe, effective products to patients internationally.
Job description
Work Flexibility
Hybrid: candidates must reside within commuting distance of Irvine, CA and be able to work onsite several days per week.
What You Will Do
- Evaluate products, product changes, and manufacturing changes to determine regulatory classification, jurisdiction, submission requirements, and approval pathways.
- Assess regulatory intelligence and evaluate evolving regulations to support local, regional, and global regulatory strategies.
- Advise cross-functional teams on regulatory requirements throughout the product lifecycle, including concept, development, manufacturing, labeling, and commercialization activities.
- Identify potential regulatory risks, obstacles, and market access considerations, and develop compliant regulatory solutions and action plans.
- Prepare, compile, and submit regulatory filings and notifications in electronic and paper formats in accordance with applicable regulations and timelines.
- Monitor regulatory authority review processes, 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 and project efficiencies.
- Review quality, preclinical, clinical, and manufacturing documentation to assess submission readiness and compliance with regulatory requirements.
- Develop and update internal monitoring and metric systems to drive optimization in regulatory submission planning.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or a related discipline.
- Minimum 4 years of regulatory affairs experience within 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 activities.
Preferred Qualifications
- Master’s degree in Regulatory Science or a related scientific discipline.
- Regulatory Affairs Certification (RAC).
- Experience supporting interactions with regulatory authorities and inspections.
- Experience providing regulatory support for clinical, preclinical, quality, or manufacturing activities.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or a related discipline.
- Minimum 4 years of regulatory affairs experience within 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 activities.
- Master’s degree in Regulatory Science or a related scientific discipline.
- Regulatory Affairs Certification (RAC).
- Experience supporting interactions with regulatory authorities and inspections.
- Experience providing regulatory support for clinical, preclinical, quality, or manufacturing activities.
Benefits
- Medical, Dental & Vision
- Prescription Drug Insurance
- Critical Illness Insurance
- Accident Insurance
- Hospital Indemnity Insurance
- Personalized Healthcare Support
- Wellbeing Program
- Tobacco Cessation Program
- Health Savings Account (HSA)
- Flexible Spending Accounts (FSAs)
- 401(k) Plan
- Employee Stock Purchase Plan (ESPP)
- Basic Life & AD&D Insurance
- Short-term Disability Insurance
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.