Senior Product and Regulatory Counsel

🔥 52 minutes ago

🐻 Alaska, Iowa, +7 more states – Remote

🐻 Alaska – Remote 🌾 Iowa – Remote 🌾 Nebraska – Remote 🎸 Mississippi – Remote 🏰 Missouri – Remote 🗿 South Dakota – Remote ⚔️ Virginia – Remote ⛰️ West Virginia – Remote 🧀 Wisconsin – Remote

💵 $191k - $260k / year

⏰ Full Time

🟠 Senior

⚖️ Legal Counsel / General Counsel

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ŌURA

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

🏭 Manufacturing

💼 Consulting

Healthcare • Manufacturing • Consulting

ŌURA is a company that produces smart rings designed to provide in-depth health metrics and insights. The Oura Ring tracks a variety of health-related data such as sleep patterns, heart rate, activity levels, and stress. It aims to help users live healthier and more productive lives through accurate biometrics tracked via a comfortable ring worn all day and night. With features that benefit women's health, heart health, and overall wellness, ŌURA rings are marketed as both technologically advanced and user-friendly devices for personal health monitoring.

📋 Description

• 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. • Independently drive legal and regulatory strategy for complex initiatives involving wellness features, SaMD, AI-enabled functionality, and emerging health technologies. • Advise on healthcare compliance considerations, including the Anti-Kickback Statute, product strategy, commercial models, research arrangements, and strategic partnerships. • Establish and refine governance frameworks integrating regulatory, privacy, clinical, product, and commercial considerations. • Advise on product legal requirements, claims, user-facing terms, disclosures, consent flows, and commercialization documentation. • Counsel teams on AI-enabled and algorithm-driven health features, including validation, transparency, monitoring, and global regulatory frameworks. • Review labeling, promotional materials, and marketing claims for compliance. • Advise on post-market obligations, change control, product updates, and regulatory-authority interactions. • Develop senior-leadership briefings on FDA, EU MDR, and other regulatory developments and translate them into business guidance. • Manage external counsel, consultants, and internal stakeholders on specialized regulatory matters.

🎯 Requirements

• Juris Doctor (J.D.) degree from an accredited U.S. law school • Active license to practice law in the United States • Significant relevant legal experience advising on U.S. medical device, healthcare, digital health, or regulated technology products; 10+ years preferred • Deep expertise in U.S. medical device regulatory frameworks, including general wellness products, SaMD, clinical evaluation, labeling, and post-market obligations • Demonstrated experience advising on 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 • Ability to identify and mitigate risk across privacy, consumer protection, product governance, and marketing claims • Experience operating within highly cross-functional product organizations and influencing product strategy • Exceptional judgment and communication skills, translating complex legal and regulatory requirements into practical guidance • Track record of owning complex matters independently and advising senior leaders • Preferred: experience with wearable technology, connected health products, or consumer health platforms • Preferred: familiarity with AI and machine-learning regulatory frameworks, including FDA guidance and the EU AI Act • Preferred: prior in-house, government, medtech, digital health, or regulated consumer technology experience • Preferred: experience advising on clinical studies or research activities involving regulated products

🏖️ 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