Staff International Regulatory Affairs Specialist

Staff International Regulatory Affairs Specialist

Irvine, CA

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.

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.

What You Will Need

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.

$110,100 - $183,400 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.