Associate General Counsel, Senior Director of Regulatory Compliance & Privacy

At Oura, our mission is to empower every person to own their inner potential. With our award-winning Oura Ring and app, we help over 2.5 million people turn insights about sleep, activity, and readiness into healthier, more balanced lives. We believe that starts from within — by creating a culture where our team feels supported, included, and inspired to do their best work. Our values guide how we show up for each other and our community every day.

We have offices in San Francisco, San Diego and Los Angeles for those who prefer hybrid or office settings. Oura employees in other major cities (like Boston and New York) occasionally gather informally at local co-working locations.

The AGC, Senior Director of Regulatory Compliance & Privacy will provide strategic legal guidance on all aspects of compliance on behalf of the global org, including global health product, corporate, and privacy compliance programs, ensuring Oura’s wearable technology and healthcare solutions adhere to legal and ethical standards. Reporting to the VP of IP and Regulatory Compliance, this role will be responsible for advising on regulatory risk, marketing claims, product labeling, corporate compliance initiatives, and will oversee the privacy compliance function at Oura, including oversight of Privacy Counsel and Privacy Specialist. This is a high-impact leadership role that requires the ability to proactively assess risk, develop scalable compliance frameworks, and influence cross-functional teams. The successful candidate will possess expertise in FDA frameworks governing digital health products, including wearable devices and related software, including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and AI/ML-enabled health solutions, and demonstrate a strong understanding of and experience with corporate compliance programs. This role offers an opportunity to play a key role in a fast-paced, innovative environment, balancing privacy and regulatory compliance with commercial objectives.

What you will do: 

FDA & Global Regulatory Compliance:

• Serve as the primary legal advisor on FDA, EU MDR, and other global health compliance requirements, and corporate regulatory risk for wearable-based health technology.
• Provide strategic counsel on FDA oversight, regulatory submissions, and compliance strategies for biometric tracking, AI-driven diagnostics, real-world data applications, and health and wellness claims.
• Provide legal and regulatory oversight for clinical studies and evidence generation, including IRB approvals, informed consent, and compliance with FDA, Common Rule, EU MDR, and GDPR requirements for human subjects research, and retrospective studies.
• Oversee labeling and marketing compliance, ensuring that product claims align with legal requirements while maintaining competitive positioning, and advise on permissible health claims, ensuring compliance with FDA, FTC, and global consumer protection laws.
• Serve as a key legal advisor on regulatory enforcement matters, including FDA warning letters, FTC inquiries, and global regulatory audits.
• Monitor evolving regulatory guidance and guide teams on risk-based approaches to regulatory compliance in product development, clinical validation, and market positioning.
• Oversee compliance with Quality System Regulation (QSR) and Good Manufacturing Practices (GMPs), as well as post-market compliance, including Medical Device Reporting (MDR), product recalls, corrective actions, and field safety notices, ensuring alignment with FDA expectations.
• Advise on cross-border regulatory challenges, ensuring seamless market entry while managing jurisdictional risks.
• Collaborate with the supply chain team to oversee global trade compliance, ensuring adherence to import/export regulations, customs laws, and free trade agreements affecting medical devices and consumer health products.
• Provide legal guidance on supply chain risk management, including restricted party screening, export controls (EAR & ITAR), and compliance with OFAC sanctions programs.
• Support classification of products under Harmonized Tariff Schedule (HTS) codes and ensure accurate country-of-origin documentation.
• In collaboration with Oura’s healthcare and government relations teams, represent the company in interactions with regulators, trade associations, and industry groups, shaping policy discussions around digital health regulation.
• Provide updates to leadership on regulatory and corporate compliance risks, emerging trends, and strategic mitigation efforts.

Privacy Compliance Oversight:

• Manage Oura’s privacy team to ensure data privacy program compliance with HIPAA/HITECH, GDPR, new omnibus U.S. state privacy laws, and other rele