Associate General Counsel, Senior Director of Regulatory Compliance & Privacy
- San Francisco, CA
- Permanent
- Full-time
- 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.
- Manage Oura’s privacy team to ensure data privacy program compliance with HIPAA/HITECH, GDPR, new omnibus U.S. state privacy laws, and other relevant data protection laws in the context of health data collection and processing.
- Oversee the Privacy Counsel and Privacy Specialist, driving the compliant aspects of privacy, including responsibility for ensuring maintenance of data inventories, PIAs, and data subject rights requests to ensure robust data privacy practices are integrated into regulatory submissions and compliance strategies.
- Conduct internal audits and investigations related to privacy and compliance, including working with Oura’s Data Privacy Officer on data protection impact assessments, audits, and incident response.
- Develop and deliver training programs, and collaborate with internal and external stakeholders to promote a culture of compliance and integrity.
- Develop and oversee the company’s ethics and compliance program, ensuring alignment with global best practices and regulatory expectations.
- Lead anti-bribery and anti-corruption (ABAC) compliance, ensuring adherence to FCPA, UK Bribery Act, and other international frameworks.
- Implement and manage corporate compliance policies, including conflicts of interest, whistleblower protections, and code of conduct.
- Drive internal compliance training and awareness programs to strengthen ethical decision-making and regulatory adherence across the organization.
- Partner with the Sr. Director – Global Risk & Asset Protection on investigative matters related to regulatory compliance, ethics concerns, and corporate misconduct.
- 10+ years of legal experience, including both private practice and in-house, in corporate healthcare regulatory compliance, privacy compliance, and ethics programs, preferably in digital health, diagnostics, wearables, or consumer health technology.
- 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, with a 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, ensuring legal compliance while enabling innovation.
- JD degree with bar admission in at least one U.S. jurisdiction.
- 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
- Region 1: $191,000-$239,000
- Region 2: $178,000-$223,000
- Region 3: $165,000-$206,000
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