Senior Product and Regulatory Counsel

Oura Oura · Consumer · NORTH AMERICA · Legal

Senior Product and Regulatory Counsel for a consumer wellness technology company, focusing on guiding the development, validation, and commercialization of both general wellness and regulated Software as a Medical Device (SaMD) features. The role involves navigating global regulatory frameworks (FDA, MDR), advising on AI-enabled health features, clinical validation, and ensuring compliance with consumer protection laws.

What you'd actually do

  1. 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.
  2. 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.
  3. Establish scalable product development governance frameworks that integrate regulatory, privacy, clinical, and product requirements throughout the product lifecycle.
  4. Provide comprehensive legal support for pre-market requirements, including the review of user-facing terms, disclosures, and consent mechanisms to ensure global alignment.
  5. 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.

Skills

Required

  • Juris Doctor (J.D.) degree
  • active license to practice law in the United States
  • 8+ years of relevant legal experience
  • Deep understanding of U.S. medical device regulations and guidance
  • Familiarity with international medical device regulatory frameworks including EU MDR and ISO standards
  • Ability to identify and mitigate risks across diverse regulatory domains
  • Demonstrated ability to operate effectively within cross-functional product teams
  • Collaborative mindset

Nice to have

  • Experience working with wearable technology, connected health products, or consumer health platforms
  • Familiarity with emerging regulatory frameworks governing AI and machine learning in medical devices
  • Prior in-house experience at the FDA or in a medtech, digital health, or regulated consumer technology company
  • Experience advising on clinical studies and/or research activities involving regulated products

What the JD emphasized

  • medical device regulatory requirements
  • FDA submissions
  • global filings
  • regulated product features
  • global standards
  • product development governance frameworks
  • regulatory
  • privacy
  • clinical
  • product requirements
  • product lifecycle
  • pre-market requirements
  • user-facing terms
  • disclosures
  • consent mechanisms
  • global alignment
  • AI-enabled
  • algorithm-driven health features
  • model transparency
  • validation
  • performance monitoring
  • emerging regulatory frameworks governing machine learning
  • clinical validation strategies
  • clinical studies
  • institutional review requirements
  • research partnerships
  • real-world evidence
  • regulatory submissions
  • promotional materials
  • labeling
  • marketing claims
  • consumer protection laws
  • advertising standards
  • regulatory requirements
  • post-market requirements
  • change controls
  • interactions with regulatory authorities
  • international markets
  • jurisdictions
  • evolving FDA
  • EU MDR
  • global regulatory developments
  • regulation of wearables
  • AI-enabled technology
  • external counsel
  • specialized consultants
  • complex regulatory filings
  • specialized product legal matters
  • U.S. medical device regulations
  • FDA frameworks
  • general wellness products
  • software as a medical device
  • clinical evaluation
  • labeling
  • post-market obligations
  • FDA submissions
  • medical devices
  • SaMD
  • regulated features
  • international medical device regulatory frameworks
  • EU MDR
  • ISO standards
  • risks
  • regulatory domains
  • data privacy
  • consumer protection
  • marketing claims
  • cross-functional product teams
  • product strategy
  • highly iterative development environments
  • complex legal requirements
  • actionable, practical advice
  • fast-paced environment
  • wearable technology
  • connected health products
  • consumer health platforms
  • emerging regulatory frameworks governing AI and machine learning
  • medical devices
  • FDA guidance
  • EU AI Act
  • in-house experience
  • FDA
  • medtech
  • digital health
  • regulated consumer technology company
  • clinical studies
  • research activities
  • regulated products