Staff International Regulatory Affairs Specialist
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From Stryker’s original posting
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. 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…
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