Regulatory Affairs Program Manager, Digital Health

Regulatory Affairs Program Manager, Digital Health. Responsible for coordinating and managing regulatory activities across the Digital Unit (DU).

Requirements

• BS or comparable required.
• Minimum of 10 years' experience in Regulatory Affairs, ideally within the medical device or digital health industries.
• Minimum of 3 years focused on software-driven health technologies.
• Experience with regulatory compliance for digital health software not classified as medical devices, including AI-enabled consumer health platforms, and connected technologies.
• Expertise in digital health regulatory affairs, with knowledge of relevant frameworks and guidance outside medical device pathways.
• Strong track record of leading regulatory strategy for digital health solutions in cross-functional environments.
• Demonstrated knowledge of data protection, cybersecurity, and digital trust frameworks.
• Experience with digital product compliance documentation and voluntary compliance schemes.
• Experience working in a global matrix environment and managing interactions with regulators, privacy authorities, and standards organizations.

Benefits

• Competitive salaries, annual bonus and 401(k) with company match
• Comprehensive medical, dental, vision coverage
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance
• 12 Paid Holidays
• On-Site Child Daycare, Café, Fitness Center