[Skip to main content](#main-content) [OpenNash Jobs](https://jobs.opennash.com/) [Hiring report](/reports/hiring/) · [All Stryker jobs](https://jobs.opennash.com/companies/stryker/) · [Search jobs](/search/) Stryker · Irvine, California # Staff International Regulatory Affairs Specialist Irvine, California Senior individual contributor $110,100 - $183,400 Legal & Compliance Listed on Stryker’s official careers site. Listed as of October 18, 2026. Check that it is still open and apply there. [Apply on Stryker’s careers site →](https://stryker.wd1.myworkdayjobs.com/StrykerCareers/job/Irvine-California/Staff-International-Regulatory-Affairs-Specialist_R568867) [OpenNash Jobs](https://jobs.opennash.com/) / [Stryker](https://jobs.opennash.com/companies/stryker/) / Staff International Regulatory Affairs Specialist ## 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. 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. $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. ## At a glance - Posted by the employer: Not stated - First seen by OpenNash: Aug 21, 2026 - Last checked: Oct 18, 2026 - Listed for: 58 days - Location: Irvine, California - Pay: $110,100 - $183,400[Apply on Stryker’s careers site →](https://stryker.wd1.myworkdayjobs.com/StrykerCareers/job/Irvine-California/Staff-International-Regulatory-Affairs-Specialist_R568867) ## More jobs at Stryker ### [Staff Quality Compliance Engineer](https://jobs.opennash.com/companies/stryker/jobs/0c53130f37810e00d63d/) Irvine, California ### [Account Manager - North Orange County - Peripheral Vascular](https://jobs.opennash.com/companies/stryker/jobs/d6f48459542129a4cb39/) Irvine, California ### [Assembler I - 2nd Shift - $23.30/hr + $1.50/hr Shift Differential](https://jobs.opennash.com/companies/stryker/jobs/78f47ae12738e30d7985/) Irvine, California ### [Assembler II - 2nd Shift - $24.80/hr + $1.50/hr Shift Differential](https://jobs.opennash.com/companies/stryker/jobs/bc578ff504e79498b38c/) Irvine, California ### [Associate Manager, Quality Assurance](https://jobs.opennash.com/companies/stryker/jobs/3329071a9e0e6828b334/) Irvine, California ## Similar jobs at other companies ### [Principal Regulatory Affairs Specialist](https://jobs.opennash.com/companies/cardinal-health/jobs/33905438205fffb92ba7/) Cardinal Health · International ### [Senior Specialist, International Regulatory Affairs TMTT](https://jobs.opennash.com/companies/edwards-lifesciences/jobs/958e2cc25087dcbe3743/) Edwards Lifesciences · USA - California – Irvine ### [Global Regulatory Affairs Manager, Oncology](https://jobs.opennash.com/companies/gsk/jobs/09fdd8d7e12226e3ad65/) GSK · Rockville, Maryland, United States of America ### [Director, Global Regulatory Affairs (GRL)](https://jobs.opennash.com/companies/daiichi-sankyo/jobs/23bdbd6a298974011fee/) Daiichi Sankyo · Basking Ridge, NJ, USA ### [Director, Regulatory Affairs, Companion Diagnostics](https://jobs.opennash.com/companies/daiichi-sankyo/jobs/fdf9cbaa775b4385105d/) Daiichi Sankyo · Basking Ridge, NJ, USA OpenNash lists jobs from employers’ own careers sites and does not handle applications. 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