Job Details

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 organization, including global health product, corporate, and privacy compliance programs. This role ensures Oura's wearable technology and healthcare solutions adhere to legal and ethical standards. Reporting to the VP of IP and Regulatory Compliance, this position advises on regulatory risk, marketing claims, product labeling, and corporate compliance initiatives, and oversees the privacy compliance function, including oversight of Privacy Counsel and Privacy Specialist. This high-impact leadership role requires proactive risk assessment, scalable compliance framework development, and influence across teams. The ideal candidate will have expertise in FDA frameworks governing digital health products, including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and AI/ML-enabled health solutions, with a strong understanding of corporate compliance programs.

What you will do:

FDA & Global Regulatory Compliance:

1. 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.
2. 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.
3. Oversee clinical studies and evidence, including IRB approvals, informed consent, and compliance with FDA, Common Rule, EU MDR, and GDPR requirements for human subjects research.
4. Ensure labeling and marketing compliance, advising on health claims to align with legal requirements while maintaining competitiveness.
5. Act as a legal advisor on regulatory enforcement, including FDA warning letters, FTC inquiries, and audits.
6. Monitor regulatory guidance and guide teams on risk-based compliance in product development, clinical validation, and market positioning.
7. Oversee compliance with Quality System Regulation (QSR), Good Manufacturing Practices (GMPs), and post-market activities like MDR, recalls, and safety notices.
8. Advise on cross-border regulatory challenges and collaborate with supply chain teams on trade compliance, import/export regulations, and sanctions.
9. Support classification of products under HTS codes and ensure accurate documentation.
10. Represent Oura in interactions with regulators and industry groups, shaping policy discussions on digital health regulation.
11. Report on regulatory risks, trends, and mitigation strategies to leadership.

Privacy Compliance Oversight:

1. Manage the privacy team to ensure compliance with HIPAA/HITECH, GDPR, CCPA/CPRA, and relevant data laws.
2. Oversee privacy functions, including data inventories, PIAs, and handling data subject rights requests.
3. Conduct audits and investigations, working with the Data Privacy Officer on impact assessments and incident responses.
4. Develop and deliver privacy training and promote a culture of compliance.

Corporate Compliance & Ethics Program Leadership:

1. Develop and oversee the company's ethics and compliance program.
2. Lead anti-bribery and anti-corruption initiatives, ensuring adherence to FCPA, UK Bribery Act, and other frameworks.
3. Implement policies on conflicts of interest, whistleblower protections, and code of conduct.
4. Drive internal training and awareness programs on ethics and compliance.
5. Partner on investigations related to regulatory compliance and misconduct.

Requirements

• 10+ years of legal experience in healthcare regulatory compliance, privacy, and ethics, preferably in digital health or consumer health technology.
• Deep expertise in FDA regulations, biometric tracking, AI diagnostics, and digital health compliance.
• Strong understanding of FTC advertising laws and global health product labeling laws.
• Proven experience developing privacy compliance programs in regulated environments, with knowledge of HIPAA, GDPR, CCPA/CPRA.
• Experience managing corporate ethics and compliance programs, including anti-bribery initiatives.
• Ability to interpret and influence evolving regulatory frameworks.
• JD degree with bar admission in at least one U.S. jurisdiction.

Benefits

• Competitive salary and equity packages
• Health, dental, vision insurance, and mental health resources
• An Oura Ring and employee discounts
• Paid time off, holidays, and wellness days
• Paid sick and parental leave

Note: Salary ranges vary by location, and candidates in certain states are not considered.

Oura is committed to diversity and inclusion. We prohibit discrimination and harassment and provide accommodations for individuals with disabilities.

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