Director, Regulatory Affairs Advertising and Promotion
Gilead SciencesFull Time
Expert & Leadership (9+ years)
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.
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.
Wearable health monitoring smart ring
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.