Senior Product and Regulatory Counsel

Ōura

5d • $191,000 - $260,000 • Remote

About The Position

Our mission at Oura is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles.
Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office.
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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree