Senior Regulatory Affairs Specialist

ŌURA

Senior Regulatory Affairs Specialist at Oura supporting regulatory operations for software as a medical device products. Ensuring compliance and efficiency across product lifecycle with collaboration across teams.

Posted 4/20/2026full-timeRemote • Alaska, Iowa, Mississippi, Montana, New York, South Dakota, Vermont, Virginia, West Virginia, Wisconsin • 🇺🇸 United StatesSenior💰 $151,300 - $178,000 per yearWebsite

About the role

Key responsibilities & impact

Support regulatory operations 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, and change assessment logs
Partner with Regulatory Affairs leads to support FDA, EU, and other global market activities as applicable
Ensure submission content is complete, version-controlled, and aligned with internal document control requirements
Support design change assessments and help determine regulatory filing impact for software updates, labeling changes, and product modifications
Manage health authority document requests, submission calendars, and deadlines
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

What you’ll 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
Excellent written and verbal communication skills
Ability to manage multiple priorities and deadlines with strong attention to detail

Benefits

Comp & perks

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
Amazing culture of collaborative and passionate coworkers

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory operationsregulatory submissionsregulatory documentationsubmission trackersproduct registrationschange assessmentUDIISO 13485IEC 62304ISO 14971

Soft Skills

project coordinationorganizationdocument managementwritten communicationverbal communicationattention to detailability to manage prioritiescollaborationefficiency improvement