Global Regulatory Affairs Specialist (Hybrid)

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

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.