Associate General Counsel, Oura
Senior Director of Regulatory Compliance & Privacy
$165-239k
Salary varies by location; + Equity
Expert level
Boston
Los Angeles
New York
San Francisco Bay Area
Remote from US
More information about location
Health monitoring smart ring
Be an early applicant
Health monitoring smart ring
501-1000 employees
B2CRetailPersonal healthFashionFitnessWellbeingeCommerceMedTech
Be an early applicant
$165-239k
Salary varies by location; + Equity
Expert level
Boston
Los Angeles
New York
San Francisco Bay Area
Remote from US
More information about location
501-1000 employees
B2CRetailPersonal healthFashionFitnessWellbeingeCommerceMedTech
Company mission
Oura's mission is to make health a daily practice.
Role
Who you are
- 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
What the job involves
- 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
- 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
Our take
As smart watches with health and wellbeing monitoring functions are now an everyday norm, Oura is offering similar wearable technology with its series of rings. It’s one of a number of companies gaining serious traction in the market, along with the likes of Circular and Movano.
The company gained an early profile after its collaboration with Gucci which created mainstream publicity and may have given it a leg up on the competition. With the smart ring market forecast to keep growing, Oura certainly finds itself in a promising position as it moves to build out its operations and refine the product.
The bottom line for Oura will be customer satisfaction and demand, which does make its mixed reviews so far a little troubling. That said, the announcement of its new "Circles" social feature, on top of an integration with InsideTracker and acquisition of "wave to pay" company Proxy, all look set to increase the functionality of the ring and could well win more consumers over.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
Top investors
9% employee growth in 12 months
Company
Funding (last 2 of 10 rounds)
Dec 2024
$125m
SERIES D
Nov 2024
$75m
SERIES D
Total funding: $354.6m
Company benefits
- Beautiful workspaces in San Francisco by Pier 31, Oulu and Helsinki (Finland)
- Amazing culture of collaborative and passionate coworkers
- Wellness benefits
- An Oura Ring of your own
- Personal learning & development budget of 750 USD/EUR
- Unlimited course offerings from Coursera
- Five (5) total days of work time to devote to employee development training
- Equity
- Health, dental, and vision insurance
- 20 days of PTO
Company HQ
Linnanmaa, Oulu
Leadership
Tom Hale
(CEO, Not Founder)Seasoned senior board member and advisor at multiple high growth companies including Cars.com, Volara, and HomeAway.
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