Senior Product and Regulatory Counsel

We are looking for a Product and Regulatory Lead Counsel who will serve as a senior individual contributor and strategic advisor at the intersection of consumer wellness technology and regulated digital health products. This role is responsible for leading high-impact legal and regulatory strategy across Oura’s evolving portfolio, including general wellness and regulated Software as a Medical Device (SaMD) features, while operating with significant independence and influence across the company.

This role will partner closely with Product, Engineering, Science, Clinical, Regulatory Affairs, and executive stakeholders to help shape product direction, guide complex risk-based decisions, and support the development, validation, and commercialization of innovative health technologies. The ideal candidate combines deep subject-matter expertise, strong judgment, and the ability to influence cross-functional teams.

• →Serve as a primary legal advisor on medical device and digital health regulatory matters, partnering with Regulatory Affairs and cross-functional teams to support FDA submissions, global filings, and legal strategy for regulated product features.
• →Provide strategic legal counsel throughout the product lifecycle, from early ideation through launch and post-market evolution, helping teams navigate regulatory requirements while preserving product quality and user experience.
• →Independently drive legal and regulatory strategy for complex, high-visibility initiatives involving wellness features, SaMD, AI-enabled functionality, and other emerging health technologies.
• →Advise on healthcare compliance considerations, including fraud and abuse laws such as the Anti-Kickback Statute, in connection with product strategy, commercial models, research arrangements, and strategic partnerships.
• →Establish and refine scalable governance frameworks that integrate regulatory, privacy, clinical, product, and commercial considerations into product development and decision-making.
• →Advise on product legal requirements, including product claims, user-facing terms, disclosures, consent flows, and documentation needed to support compliant commercialization in multiple jurisdictions.
• →Counsel teams on legal and regulatory issues related to AI-enabled and algorithm-driven health features, including validation, transparency, monitoring, and evolving global regulatory frameworks.
• →Review labeling, promotional materials, and marketing claims for compliance with medical device, consumer protection, and advertising requirements.
• →Advise on post-market obligations, change control, product updates, and interactions with regulatory authorities.
• →Develop briefings for Senior leadership on significant developments in FDA, EU MDR, and other global regulatory regimes affecting wearables, digital health, healthcare, and AI-enabled technologies, and translate those developments into actionable business guidance.
• →Manage external counsel, consultants, and internal stakeholders on specialized regulatory matters, while serving as a trusted internal expert and thought partner on novel legal issues.

• Operates as a recognized subject-matter authority in product and regulatory counseling for digital health, healthcare, and medical device issues
• Shapes strategy on the company’s most complex product, regulatory, and commercialization decisions
• Influences senior cross-functional stakeholders through expertise, judgment, and credibility rather than people management authority
• Builds scalable frameworks and durable guidance that enable the business to move faster with appropriate risk management
• Anticipates emerging regulatory issues and helps position Oura proactively for future product and market opportunities

We would love to consider you for this role if you have:

• Juris Doctor (J.D.) degree from an accredited U.S. law school and active license to practice law in the United States.
• Significant relevant legal experience, including substantial experience advising on U.S. medical device, healthcare, digital health, or other regulated technology products; 10+ years preferred.
• Deep expertise in U.S. medical device regulatory frameworks and guidance, including 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 relevant ISO standards.
• Strong ability to identify and mitigate risk across adjacent domains, including privacy, consumer protection, product governance, and marketing claims.
• Proven ability to operate effectively within highly cross-functional product organizations and influence product strategy in fast-moving, iterative development environments.
• Exceptional judgment and communication skills, with the ability to translate complex legal and regulatory requirements into clear, practical guidance for non-legal stakeholders.
• A track record of owning complex matters with a high degree of independence and serving as a trusted advisor to senior leaders.

• 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, including FDA guidance and the EU AI Act.
• Prior in-house experience, government experience, or experience within a medtech, digital health, or regulated consumer technology company.
• Experience advising on clinical studies and/or research activities involving regulated products.

This is a remote U.S. role. We have offices in San Francisco, San Diego, and Los Angeles for those who prefer hybrid or office settings, and Oura employees in other major cities occasionally gather informally at local co-working locations.