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Oura is seeking a Senior Product and Regulatory Counsel to serve as a strategic legal advisor at the intersection of consumer wellness technology and regulated digital health products. This is a senior individual contributor role with significant independence and influence across the organization.
You will partner closely with Product, Engineering, Science, Clinical, Regulatory Affairs, and executive leadership to shape product direction, guide complex risk-based decisions, and support the development, validation, and commercialization of innovative health technologies.
Key responsibilities include:
- Serve as primary legal advisor on medical device and digital health regulatory matters, partnering with Regulatory Affairs on FDA submissions, global filings, and legal strategy for regulated product features
- Provide strategic legal counsel throughout the product lifecycle, from ideation through launch and post-market evolution
- Independently drive legal and regulatory strategy for complex initiatives involving wellness features, Software as a Medical Device (SaMD), AI-enabled functionality, and emerging health technologies
- Advise on healthcare compliance, including Anti-Kickback Statute and fraud/abuse laws, in connection with product strategy, commercial models, research arrangements, and partnerships
- Establish and refine scalable governance frameworks integrating regulatory, privacy, clinical, product, and commercial considerations
- Advise on product legal requirements including claims, user-facing terms, disclosures, consent flows, and documentation for compliant commercialization
- Counsel teams on legal and regulatory issues related to AI-enabled and algorithm-driven health features
- Review labeling, promotional materials, and marketing claims for compliance
- Advise on post-market obligations, change control, product updates, and regulatory authority interactions
- Develop briefings for senior leadership on FDA, EU MDR, and global regulatory developments affecting wearables, digital health, and AI technologies
- Manage external counsel, consultants, and internal stakeholders on specialized regulatory matters
Success means operating as a recognized subject-matter authority, shaping strategy on complex product and regulatory decisions, influencing senior stakeholders through expertise and credibility, building scalable frameworks that enable faster business movement with appropriate risk management, and anticipating emerging regulatory issues.
