Oura
Senior Regulatory Affairs Specialist
Remote role where the employee must remain based in a particular country.
United States only
Employer listed it 6 days ago · Added 5 days ago
First listed 6 days ago and still open.
Salary
$151,300 to $178,000
Location
United States only
Timezone
US East
Contract
Full-time
Experience
Senior
Category
Other
Stated by the employer in the job description
Remote flexibility
Work from home
This is a remote role, but the employee must be based in United States. It is work from home rather than work from anywhere.
What the employer says
- Source listing states candidate location: "Remote - United States, Remote, United States"
What Nomaders makes of it
- Residency required in United States
- Payroll and tax are likely handled in that country only
The quotes above are the employer's own words; the reading is ours. Always check the original listing and employment terms before working from another country.
About the role
Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles.
Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office.
We are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy/operations for our Software as a Medical Device (SaMD) portfolio. This role will help drive compliant and efficient execution of regulatory activities across the product lifecycle, including submission support, document management, change assessments, registrations, regulatory intelligence, and inspection/audit readiness.
The ideal candidate brings hands-on experience in medical device or digital health regulatory affairs, strong operational discipline, and the ability to work cross-functionally with quality, engineering, product, clinical, and legal teams in a fast-paced environment.
What You Will Do
Lead regulatory and quality strategy for product development, approval, and lifecycle management for wellness and regulated features.
Support regulatory operations lead for SaMD products across development, submission, launch, and post-market phases
Coordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondence
Maintain regulatory documentation, including:
submission trackers
product registrations/listings
regulatory commitments
approvals and clearance records
change assessment logs
Support design change assessments and help determine regulatory filing impact for software updates, labeling changes, and product modifications
Track and communicate submission milestones, approvals, renewals, and post-market reporting requirements
Support UDI, registration, listing, and market access maintenance activities where applicable
Contribute to inspection and audit readiness by organizing regulatory evidence and ensuring documentation is current and inspection-ready
Monitor evolving regulations, guidance, and standards relevant to SaMD, and help translate changes into operational actions
Collaborate with cross-functional stakeholders to improve regulatory processes, templates, and tools for scale and efficiency
Requirements:
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
Requirements
- ·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
Benefits
- ·At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health.
- ·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
How to apply
- 1Check the flexibility label above, work from home, matches where you plan to live and work.
- 2Tailor your CV to the role at Oura, mentioning your remote working experience and working hours (US East).
- 3Apply directly on the employer's careers page using the button below. Nomaders never handles your application.
Found 5d ago. Last checked 23 Sept. Always confirm the details on the original posting, salary and location can change after publication.
Listing sourced from Company boards.
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