Senior Regulatory Affairs Specialist

ŌURA

Remote, US
Base: region 1 $151,300-$178,000; region 2 $138,55...
Remote
5+ years regulatory affairs experience
Software as a medical device samd experience
Fda medical device requirements knowledge
ŌURA is seeking a Senior Regulatory Affairs Specialist to oversee regulatory operations for its Software as a Medical Device (SaMD) portfolio. The ideal candidate will have significant experience in regulatory affairs within the medical device or digital health sectors and will work collaboratively in a fast-paced environment. This remote position offers competitive benefits and a strong emphasis on employee well-being

Job Summary

  • The mission is to empower every person to own their inner potential through award-winning products that help users gain deeper knowledge of their health.
  • This role supports regulatory operations for the Software as a Medical Device portfolio across the entire product lifecycle from development to post-market phases.
  • Employees receive competitive salary and equity packages, an Oura Ring, 20 days of paid time off, plus 13 paid holidays and flexible wellness time.

Matching Summary

Match Score: 85

ŌURA is seeking a Senior Regulatory Affairs Specialist to oversee regulatory operations for its Software as a Medical Device (SaMD) portfolio. The ideal candidate will have significant experience in regulatory affairs within the medical device or digital health sectors and will work collaboratively in a fast-paced environment. This remote position offers competitive benefits and a strong emphasis on employee well-being.

Salary

Base: Region 1 $151,300-$178,000; Region 2 $138,550-$163,000; Region 3 $127,500-$150,000; Equity: Competitive equity packages included; Benefits: Health, dental, vision, mental health, 20 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 and ISO 14971 standards
  • IEC 62304 software lifecycle standards

Nice-to-have

  • RAC certification or relevant training
  • Startup or high-growth medtech environment
  • Experience with eQMS tools
  • Cybersecurity understanding for SaMD
  • Cross-functional collaboration skills

Key Requirements

  • Bachelor's degree in scientific or engineering discipline
  • 5+ years experience in medical device regulatory affairs
  • US based location required excluding specific states

Work Rights

Not specified

Tailored Resume

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