The Senior Product and Regulatory Counsel at Oura will serve as a strategic advisor, guiding cross-functional teams through the development, validation, and commercialization of Oura’s portfolio, including general wellness and regulated Software as a Medical Device (SaMD) features. This role is pivotal in navigating complex global frameworks, such as FDA and MDR, while collaborating closely with Product, Engineering, and Clinical teams to bring high-impact innovations to market.

Key responsibilities include serving as the primary legal advisor on medical device regulatory requirements, supporting FDA submissions and global filings, and shaping the legal and regulatory strategy for regulated product features. The counsel will partner with various teams from the ideation stage to ensure features meet global standards without compromising user experience. Additionally, they will establish scalable product development governance frameworks, provide legal support for pre-market requirements, advise on AI-enabled health features, and oversee clinical validation strategies.

The ideal candidate will possess a Juris Doctor (J.D.) degree from an accredited U.S. law school and an active license to practice law in the United States, with over 8 years of relevant legal experience. A deep understanding of U.S. medical device regulations, including FDA frameworks for general wellness products and SaMD, is essential. Experience advising on or directly supporting FDA submissions for medical devices or related regulated features is required. Familiarity with international medical device regulatory frameworks, such as EU MDR and ISO standards, is also important.

Oura offers a competitive salary and equity packages, comprehensive health, dental, and vision insurance, and mental health resources. Employees receive an Oura Ring and discounts for friends and family. The company provides 20 days of paid time off, 13 paid holidays, and 8 days of flexible wellness time off, along with paid sick leave and parental leave.

Oura fosters a culture that empowers individuals to own their inner potential, emphasizing support, inclusion, and inspiration. The company is committed to helping people live healthier and happier lives, ensuring team members have the resources they need to excel both professionally and personally.