Senior Product and Regulatory Counsel
Benefits
4w PTO
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Responsibilities:
- Serve as the primary legal advisor on medical device regulatory requirements.
- Partner cross-functionally with Product, Science, Regulatory Affairs, and Engineering teams.
- Establish scalable product development governance frameworks.
Qualifications:
- Juris Doctor (J.D.) degree from an accredited U.S. law school; active license to practice law in the United States with 8+ years of relevant legal experience.
- Deep understanding of U.S. medical device regulations and guidance.
- Demonstrated experience advising on and/or directly supporting FDA submissions for medical devices, SaMD, or related regulated features.
Bonus Points:
- 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.
- Prior in-house experience at the FDA or in a medtech, digital health, or regulated consumer technology company.
Oura
Oura's mission is to empower every person to own their inner potential through award-winning products like the Oura Ring and its connected app. They've helped millions understand and improve their health with insights and practical steps, ensuring team members have what they need to do their best work.