Staff International Regulatory Affairs Specialist

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

Job summary

Stryker Corporation in Irvine, CA is seeking an International Regulatory Affairs Specialist to ensure timely and compliant global product registrations. You will drive operational excellence, collaborate with global teams, and influence access to safe, effective products worldwide.

The role supports hybrid or onsite work arrangements, with requirements to reside within commuting distance of Irvine, CA. A strong background in regulatory affairs and international submissions is essential.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or a related discipline.
• Minimum 4 years of regulatory affairs experience in medical device, biotech, pharma, or related regulated industry.
• Experience with international regulatory submissions and compliance across product lifecycle.

Responsibilities

• Evaluate products, changes, and manufacturing changes to determine regulatory classification and submission requirements.
• Assess regulatory intelligence and evolving regulations to support global strategies.
• Advise cross-functional teams on regulatory requirements across lifecycle stages.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in Engineering or Life Sciences

Master’s degree in Regulatory Science

Job description

Work Flexibility: Hybrid or Onsite 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.

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.

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 Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better.

We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World’s Best Workplaces!

For more information, visit: www.stryker.com