Senior Product and Regulatory Counsel
About the role
About Oura
Oura empowers people to own their inner potential through award-winning products that help users gain deeper knowledge of their readiness, activity, and sleep quality using the Oura Ring and connected app.
Role Overview
Senior Product and Regulatory Counsel serving as a lead strategic advisor at the intersection of consumer wellness technology and regulated digital health products. This role guides cross-functional teams through development, validation, and commercialization of Oura's portfolio, including general wellness and regulated Software as a Medical Device (SaMD) features.
Key Responsibilities
- Navigate complex global regulatory frameworks, including FDA and MDR requirements
- Partner with Product, Engineering, and Clinical teams on product lifecycle management
- Shepherd high-impact innovations through development and commercialization
- Provide strategic legal counsel on regulatory compliance for digital health products
Ideal Candidate
Pragmatic problem-solver with deep expertise in regulatory affairs, healthcare technology law, and SaMD regulations. Experience navigating FDA compliance and international medical device regulations required.