Senior Regulatory Affairs Specialist

Oura

Remote, United States
Base: $127,500 - $178,000 based on region; bonus/e...
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5+ years regulatory affairs experience
Software as a medical device samd experience
Fda medical device requirements knowledge
** Oura is seeking a Senior Regulatory Affairs Specialist to manage regulatory operations for its Software as a Medical Device (SaMD) portfolio, focusing on compliance throughout the product lifecycle. The ideal candidate should have extensive experience in regulatory affairs within medical devices or digital health, along with strong organizational skills and the ability to work cross-functionally. **

Job Summary

  • The role supports regulatory operations for the Software as a Medical Device portfolio across the entire product lifecycle from development to post-market phases.
  • Candidates must have hands-on experience in medical device or digital health regulatory affairs with strong operational discipline.
  • Employees receive an Oura Ring of their own, competitive salary and equity packages, plus comprehensive health and wellness benefits.

Matching Summary

Match Score: 75

** Oura is seeking a Senior Regulatory Affairs Specialist to manage regulatory operations for its Software as a Medical Device (SaMD) portfolio, focusing on compliance throughout the product lifecycle. The ideal candidate should have extensive experience in regulatory affairs within medical devices or digital health, along with strong organizational skills and the ability to work cross-functionally. **

Salary

Base: $127,500 - $178,000 based on region; Bonus/Equity: Competitive equity packages included; Benefits: Health, dental, vision, mental health, 20 days PTO, 13 holidays, 8 wellness days

Skills & Requirements

Must-have

  • 5+ years regulatory affairs experience
  • Software as a Medical Device SaMD experience
  • FDA medical device requirements knowledge
  • EU MDR framework familiarity
  • ISO 13485 standard compliance
  • IEC 62304 software lifecycle standards
  • ISO 14971 risk management standards

Nice-to-have

  • RAC certification or relevant training
  • Startup or high-growth medtech environment
  • eQMS and submission management tools
  • Cybersecurity and labeling understanding
  • Cross-functional collaboration skills
  • Fast-paced operational discipline

Key Requirements

  • Bachelor's degree in scientific or engineering discipline
  • 5+ years experience in regulatory affairs
  • Experience supporting software-based medical products
  • Familiarity with FDA, EU MDR, ISO 13485, IEC 62304, ISO 14971
  • US work authorization required

Work Rights

Must be located in US excluding specific states

Tailored Resume

Cover Letter