Staff International Regulatory Affairs Specialist

Stryker; Irvine (CA); Hybrid; USD 110,000 - 183,000; Full time

Job summary

Stryker Irvine seeks a Staff International Regulatory Affairs Specialist to drive global product registrations across diverse regulatory pathways. You will collaborate with cross-functional teams to ensure timely, compliant submissions that enable patients to access safe, effective products worldwide.

This hybrid role requires 4+ years in regulatory affairs for medical devices or related fields, with experience in international submissions, regulatory strategy, and inspections.

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.

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, including concept, development, manufacturing, labeling, and commercialization activities.
• Identify 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 per regulations and timelines.
• Monitor regulatory 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.

Skills

Regulatory affairs

International submissions

Regulatory strategy

Cross-functional collaboration

Lifecycle management

Regulatory intelligence

Inspection support

Documentation review

Project coordination

Education

Bachelor's degree in Engineering, Life Sciences, Regulatory Science, or a related discipline

Master’s degree in Regulatory Science or a related discipline

Regulatory Affairs Certification (RAC)

Job description

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