Senior Product and Regulatory Counsel

Oura
United States
Workplace: RemoteFull-timeFunction: Quality & Regulatory (Non-Software)Skills: []

Senior Product and Regulatory Counsel at a wearable wellness tech company, guiding cross-functional teams through development, validation, and commercialization of both general wellness and regulated SaMD features. Navigate FDA and MDR frameworks, collaborate with Product, Engineering and Clinical teams, and shape regulatory strategy for AI-enabled health features across global markets.

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FursaFursa
Oura
Oura
3 months ago

Senior Product and Regulatory Counsel

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Source: Company careers pageValidated by: Fursa AI
Last checked: 3 hours agoStatus: Live

Job Summary

Senior Product and Regulatory Counsel at a wearable wellness tech company, guiding cross-functional teams through development, validation, and commercialization of both general wellness and regulated SaMD features. Navigate FDA and MDR frameworks, collaborate with Product, Engineering and Clinical teams, and shape regulatory strategy for AI-enabled health features across global markets.
Location: United States
Workplace: Remote
Job Function: Quality & Regulatory (Non-Software)

Key Responsibilities

  • •Serve as the primary legal advisor on medical device regulatory requirements, partnering with Regulatory Affairs to support Oura’s FDA submissions and global filings and helping shape the legal and regulatory strategy for regulated product features.
  • •Partner cross-functionally with Product, Science, Regulatory Affairs, and Engineering teams from the ideation stage to ensure features are built to meet global standards without sacrificing user experience.
  • •Establish scalable product development governance frameworks that integrate regulatory, privacy, clinical, and product requirements throughout the product lifecycle.
  • •Provide comprehensive legal support for pre-market requirements, including the review of user-facing terms, disclosures, and consent mechanisms to ensure global alignment.
  • •Advise on legal and regulatory considerations for AI-enabled and algorithm-driven health features, including issues related to model transparency, validation, performance monitoring, and emerging regulatory frameworks governing machine learning.

Pay and Benefits

Perks:Health InsurancePaid LeaveEquity

Key Requirements

  • •Juris Doctor (J.D.) degree from an accredited U.S. law school; active license to practice law in the United States with 8+ years of relevant legal experience.
  • •Deep understanding of U.S. medical device regulations and guidance, including applicable FDA frameworks for general wellness products, software as a medical device, clinical evaluation, labeling, and post-market obligations. Demonstrated experience advising on and/or directly supporting FDA submissions for medical devices, SaMD, or related regulated features.
  • •Familiarity with international medical device regulatory frameworks including EU MDR and ISO standards.
  • •Ability to identify and mitigate risks across diverse regulatory domains, including data privacy, consumer protection, and marketing claims.
  • •Demonstrated ability to operate effectively within cross-functional product teams and influence product strategy in highly iterative development environments.
Experience:Wearable technologyDigital healthRegulated medical devices
Languages:English

Company Brief

Oura
Designs and sells the Oura Ring, a wearable device that tracks sleep, activity, and physiological signals to provide personalized health, recovery, and readiness insights via a companion app and analytics platform.
Industry: Wearables
Company Size: Large (251 to 1,000 employees)
Growth: Scaleup
Funding: Series C
Headquarters: Oulu, Finland
Founded: 2013
WebsiteLinkedIn