Oura

Associate General Counsel, Senior Director of Regulatory Compliance & Privacy

San Francisco, California, United States

$191,000 – $239,000Compensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Wearable Technology, Healthcare SolutionsIndustries

Requirements

Candidates should have expertise in FDA frameworks governing digital health products, including wearable devices and related software, such as Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), and AI/ML-enabled health solutions. A strong understanding of and experience with corporate compliance programs is also required, along with expertise in EU MDR and other global health compliance requirements. The role requires advising on regulatory risk, marketing claims, product labeling, corporate compliance initiatives, and overseeing privacy compliance functions, including managing Privacy Counsel and a Privacy Specialist. Experience with Quality System Regulation (QSR) and Good Manufacturing Practices (GMPs), as well as post-market compliance activities like Medical Device Reporting (MDR), product recalls, corrective actions, and field safety notices, is necessary. Additionally, advising on cross-border regulatory challenges and collaborating with supply chain teams on global trade compliance, including import/export regulations, customs laws, and free trade agreements affecting medical devices and consumer health products, is expected.

Responsibilities

The Associate General Counsel, Senior Director of Regulatory Compliance & Privacy will provide strategic legal guidance on global health product, corporate, and privacy compliance programs, ensuring Oura's wearable technology and healthcare solutions meet legal and ethical standards. This role involves advising on regulatory risk, marketing claims, product labeling, and corporate compliance initiatives. Responsibilities include overseeing the privacy compliance function, providing legal advice on FDA oversight, regulatory submissions, and compliance strategies for biometric tracking, AI-driven diagnostics, real-world data applications, and health and wellness claims. The role also entails providing legal and regulatory oversight for clinical studies and evidence generation, including IRB approvals, informed consent, and compliance with human subjects research regulations. Furthermore, the position involves overseeing labeling and marketing compliance, acting as a key legal advisor on regulatory enforcement matters, monitoring evolving regulatory guidance, and guiding teams on risk-based compliance approaches. The role requires overseeing compliance with QSR and GMPs, as well as post-market compliance activities, and advising on cross-border regulatory challenges to ensure smooth market entry while managing jurisdictional risks. Collaboration with the supply chain team to oversee global trade compliance is also a key responsibility.

Skills

Regulatory Compliance
Privacy Law
FDA Regulations
Digital Health
Wearable Technology
SaMD
SiMD
AI/ML
Corporate Compliance
Legal Guidance
Risk Assessment
Marketing Claims
Product Labeling

Oura

Wearable health monitoring smart ring

About Oura

Oura offers a smart ring that tracks various health metrics, including sleep patterns, heart rate variability, and physical activity. The ring uses advanced sensors to collect data, which is then analyzed and displayed through a mobile app, providing users with insights to improve their health and lifestyle. Unlike many competitors, Oura focuses on a direct-to-consumer model, selling its rings through its website and collaborating with sports teams and health institutions for additional partnerships. The goal of Oura is to help users, including athletes and those with health conditions, optimize their health through data-driven insights.

Oulu, FinlandHeadquarters
2013Year Founded
$344.1MTotal Funding
SERIES_DCompany Stage
Biotechnology, HealthcareIndustries
501-1,000Employees

Benefits

Competitive salary & equity packages
Health, dental, financial, & vision insurance
Wellness & mental health benefits
$300 per month health improvement related stipend
Flexible working hours
An Oura Ring of your own
Employee discount for friends & family
20 days of PTO

Risks

Increased competition from Samsung and Huami may pressure Oura's market share.
Criticism of cumbersome interfaces could lead users to competitors like VIV Health.
High valuation may lead to investor pressure for rapid growth, risking strategic missteps.

Differentiation

Oura's smart ring tracks over 20 biometrics, offering comprehensive health insights.
The ring's seamless wearability and precise monitoring set it apart in the market.
Oura's partnerships with sports teams validate its utility and accuracy for athletes.

Upsides

Oura raised $550M, boosting its valuation to $5.2 billion in 2024.
Integration with AI-driven insights could enhance personalized health recommendations.
Strategic partnerships with Dexcom and Essence Healthcare expand market reach into healthcare.

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