[Hiring] Senior Product and Regulatory Counsel @Ōura

Role Description

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.

What you will do

• 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.

What success looks like in this role

• 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.

Qualifications

• 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.

Preferred experience

• 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.

Location

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.

Benefits

• 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
• Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area.
• Region 1 $236,000 - $260,000
• Region 2 $212,000 - $232,000
• Region 3 $191,000 - $208,000

A recruiter can determine your Region based on your US location.

Company Description

Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws.

We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment.