Senior Manager, Regulatory Affairs, Digital Health
Olympus Corporation of the Americas
Westborough, MASSACHUSETTS, US
On-site
Digital health regulatory strategy
Global regulatory requirements
Ai and connected technologies
This role is a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU), a high-growth, global innovation hub
Job Summary
This role is a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU), a high-growth, global innovation hub.
Provide regulatory guidance, compliance risk assessment, and strategic input to digital product development and lifecycle management, ensuring compliance with applicable global regulations.
Develop and maintain SOPs, compliance frameworks, and internal guidance tailored to non-medical device digital health initiatives, and design/deliver training programs.
Matching Summary
This role is a digital-native leader responsible for shaping, coordinating, and managing regulatory activities across the Digital Unit (DU), a high-growth, global innovation hub.
Skills & Requirements
Must-have
digital health regulatory strategy
global regulatory requirements
AI and connected technologies
GDPR, HIPAA, EU AI Act
cybersecurity regulations
product lifecycle management
Nice-to-have
digital-native leader
agility and strategic foresight
change-embracing mindset
pushing back on stakeholders
Key Requirements
BS or comparable in engineering or life sciences
10+ years Regulatory Affairs experience
3+ years focused on software-driven health technologies
Demonstrated management experience
Proven experience designing, writing, and submitting regulatory filings