Oura is hiring an Associate General Counsel, Senior Director of Regulatory Compliance & Privacy to provide strategic legal leadership for our global compliance programs. In this role, you will guide our health product, corporate, and privacy initiatives, ensuring our wearable technology and healthcare solutions meet legal and ethical standards worldwide.
What You'll Do
- Serve as primary legal advisor on FDA, EU MDR, and other global health compliance requirements and corporate regulatory risk.
- Provide strategic counsel on FDA oversight, regulatory submissions, and compliance strategies for biometric tracking, AI-driven diagnostics, and health claims.
- Provide legal and regulatory oversight for clinical studies and evidence generation, including IRB approvals and informed consent.
- Oversee labeling and marketing compliance, ensuring product claims align with legal requirements.
- Serve as key legal advisor on regulatory enforcement matters, including FDA warning letters and FTC inquiries.
- Monitor evolving regulatory guidance and guide teams on risk-based approaches to compliance in product development.
- Oversee compliance with Quality System Regulation (QSR), Good Manufacturing Practices (GMPs), and post-market compliance, including Medical Device Reporting.
- Advise on cross-border regulatory challenges, ensuring seamless market entry.
- Collaborate with supply chain team to oversee global trade compliance, including import/export regulations and OFAC sanctions programs.
- Support classification of products under Harmonized Tariff Schedule codes.
- Represent the company in interactions with regulators, trade associations, and industry groups.
- Provide updates to leadership on regulatory and corporate compliance risks and mitigation efforts.
- Manage Oura’s privacy team to ensure data privacy program compliance with HIPAA/HITECH, GDPR, and U.S. state privacy laws.
- Oversee Privacy Counsel and Privacy Specialist, driving compliant aspects of privacy programs.
- Conduct internal audits and investigations related to privacy and compliance.
- Develop and deliver training programs to promote a culture of compliance and integrity.
- Develop and oversee the company’s ethics and compliance program, ensuring alignment with global best practices.
- Lead anti-bribery and anti-corruption (ABAC) compliance, ensuring adherence to FCPA and UK Bribery Act.
- Implement and manage corporate compliance policies, including conflicts of interest and whistleblower protections.
- Drive internal compliance training and awareness programs.
- Partner with the Sr. Director – Global Risk & Asset Protection on investigative matters.
What We're Looking For
- 10+ years of legal experience, including both private practice and in-house.
- Experience in corporate healthcare regulatory compliance, privacy compliance, and ethics programs.
- Deep expertise in FDA regulations, including oversight of biometric tracking, AI-driven health diagnostics, and digital health compliance.
- Strong understanding of FTC advertising regulations and global health product labeling laws.
- Proven experience in developing and implementing privacy compliance programs within a regulated environment.
- Strong understanding of global data protection laws (e.g., HIPAA, GDPR, CCPA/CPRA) and their application to health-related data.
- Expertise in managing corporate ethics and compliance programs, including anti-bribery and anti-corruption initiatives.
- Ability to interpret and influence evolving regulatory frameworks.
- JD degree with bar admission in at least one U.S. jurisdiction.
Nice to Have
- Experience preferably in digital health, diagnostics, wearables, or consumer health technology.
Team & Environment
This role reports to the VP of IP and Regulatory Compliance and oversees the Privacy Counsel and Privacy Specialist.
Benefits & Compensation
- 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
- Compensation: Region 1: $191,000-$239,000; Region 2: $178,000-$223,000; Region 3: $165,000-$206,000 + equity packages included
Work Mode
This is a hybrid position located in San Francisco, CA, San Diego, CA, or Los Angeles, CA.
Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees.
