Senior Regulatory Affairs Specialist
Ōura · Remote - United States
Posted about 3 months ago · $151,300 - $178,000
or apply directly on Ōura's site. We never take the application ourselves.
Is this posting real?
- This role has been open
- 76 days Ōura's roles stay open a median of 87 days
- Reposted
- No
- Salary listed
- Yes 77% of Ōura's roles list one
- Ghost-job risk at Ōura
- high 111 stale, 2 reposted of 111 open
- Hiring momentum
- 159 roles opened in the last 90 days ↑ up vs. the prior 90 days
- Last confirmed on the employer's board
- 2026-10-29
Measured from postings appearing on and disappearing from Ōura's own greenhouse board since 2026-08-03. Full hiring picture for Ōura.
About this role
The Senior Regulatory Affairs Specialist at ŌURA will be responsible for supporting regulatory strategy and operations for the company's Software as a Medical Device (SaMD) portfolio. This role involves leading regulatory and quality strategies, coordinating regulatory submissions, maintaining documentation, and ensuring compliance throughout the product lifecycle. The specialist will also collaborate with cross-functional teams to enhance regulatory processes and stay updated on relevant regulations.
- benefits
- 3/5
- freshness
- 1/5
- career value
- 4/5
- role clarity
- 4/5
- pay transparency
- 5/5
Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Ōura as an employer.
What you need
- Bachelor’s degree in a scientific, engineering, healthcare, or related discipline
- 5+ years of experience in regulatory affairs or regulatory operations within medical devices, digital health, or other regulated healthcare products
- Experience supporting software-based medical products or SaMD
- Familiarity with key regulatory frameworks and standards, such as FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, ISO 14971
- Experience compiling and maintaining regulatory documentation in a controlled environment
- Strong project coordination, organization, and document management skills
Nice to have
- Experience supporting 510(k), De Novo, technical documentation, or international registrations
- Familiarity with eQMS, document control, and submission management tools
- Experience with software change assessments, traceability, and lifecycle documentation
- Understanding of cybersecurity, labeling, and post-market requirements for SaMD
- RAC certification or other relevant regulatory training is a plus
What you get
- Competitive salary and equity packages
- Health, dental, vision insurance, and mental health resources
- An Oura Ring of your own plus employee discounts for friends & family
- 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
- Paid sick leave and parental leave
Worth weighing
- No specific salary listed, but ranges provided based on location
- Candidates from certain states are not being considered for this role
- The role requires collaboration across multiple teams, which may indicate a dynamic work environment
- The company emphasizes a fast-paced and high-growth setting, which may involve significant workload and pressure
Summarised from Ōura's posting. Read the full original.
Listed by Ōura on their greenhouse job board, last confirmed open on 2026-10-29. PitchMeAI is not the employer.
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