Senior Manager, Regulatory Affairs, Digital Health
Olympus Corporation of the AmericasMassachusetts, United States
Posted November 5, 2025
117068 - 163896 USD year
Full Time
About the Company
Olympus is a global medical technology company that partners with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment.
Job Description
We are seeking a Senior Manager, Regulatory Affairs, Digital Health to lead our digital-native regulatory strategy and compliance efforts. This role will be responsible for shaping, coordinating, and managing regulatory activities across our Digital Unit (DU), ensuring compliance with applicable global requirements while proactively navigating evolving regulatory landscapes.
Requirements
- BS or comparable in engineering or life sciences required
- Minimum of 10 years of Regulatory Affairs experience, ideally within the medical device or digital health industries
- Minimum of 3 years focused on software-driven health technologies
- Demonstrated management experience in a matrix organization
- Proven experience designing, writing, and submitting regulatory filings and securing approvals in spaces aligned to the digital health product portfolio
- Strong knowledge of frameworks and standards outside traditional medical device pathways
Benefits
- Competitive salaries
- Annual bonus
- 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
