Hiring: Staff International Regulatory Affairs Specialist Company: Stryker Location: Irvine, CA Job Posted Time: 2026-09-11 11:22:45 Employment Type: Hybrid Target Skills & Keywords : Regulatory Compliance About the job Experience: •4 years of regulatory affairs experience within the medical device, biotechnology, pharmaceutical, or related regulated industry. •Minimum 4 years of regulatory affairs experience within the medical device, biotechnology, pharmaceutical, or related regulated industry. Required Skills: •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. Qualifications: •Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or a related discipline. •Master’s degree in Regulatory Science or a related scientific discipline. Compensation: •$110,100 - $183,400 / year •Flexible work environment (work from home / hybrid options) Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!