Regulatory Program Manager, Health
Core
Drive global launch of regulated health features and manage regulatory submissions, quality systems, and policy engagements for health products.
Role type
Senior Program Manager (Regulatory & Quality)
Builds
Regulated health features and product launches
Domain
Health technology / Medical devices
Required skills
Regulatory submission management, Quality system management, Cross-functional collaboration, Risk assessment, Project timeline management, Stakeholder communication
Preferred skills
Design Controls expertise, International regulatory process knowledge, Medical device policy engagement
Technologies
Project management and reporting software
Responsibilities
Oversee regulatory submissions, launch readiness, design changes, and medical device policy activities; Establish critical path and coordinate activities with cross-functional partners; Communicate program status and escalate risks; Manage Quality Design History File (DHF) documentation timelines
Seniority
Senior, hands-on IC