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Senior Specialist Regulatory Affairs

Stryker · Irvine, CA

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RegulatoryFull-time$96k–$160kCompany career page

The apply link worked recently (not employer-confirmed).

What they're looking for

  • Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or related field
  • Minimum 2 years of Regulatory Affairs experience
  • Experience preparing, reviewing, or supporting regulatory submissions and documentation
  • Ability to interpret and apply regulatory requirements in regulated environments
  • Master's degree in Regulatory Science (preferred)
  • Regulatory Affairs Certification (RAC) (preferred)
  • Experience with medical devices or regulated healthcare products (preferred)

What you'll be doing

  • Assess regulatory intelligence and requirements for local, regional, and global strategies
  • Evaluate products and changes for regulatory classification, submission requirements, and compliance impact
  • Prepare, compile, and submit regulatory documentation per applicable global regulations
  • Monitor regulatory authority review activities and support agency communications
  • Provide regulatory guidance to cross-functional teams during product development and post-market activities

Privacy & handoff

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Date posted4 days ago
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