Associate Director, Device Regulatory Affairs
Core
Lead global regulatory strategy and execution for Class III implantable medical devices, managing a team and serving as a senior representative for health authorities.
Role type
Senior management regulatory affairs lead (Class III devices)
Builds
Regulatory submission plans and documentation for high-risk medical devices
Domain
Medical devices / Regulatory Affairs
Required skills
Regulatory strategy, FDA submissions, EU MDR technical documentation, Class III implantable device experience, combination product experience, team leadership, cross-functional partnership
Preferred skills
Advanced degree
Technologies
FDA submissions, EU MDR
Responsibilities
Lead global regulatory strategy for Class III medical device programs; Direct preparation, review, and execution of major regulatory submissions; Serve as senior regulatory lead for interactions with FDA, EU notified bodies, and UK approved bodies; Provide regulatory leadership for product development, design changes, manufacturing changes, labeling, clinical evidence, and risk management; Lead and mentor global regulatory staff and cross-functional teams
Seniority
Senior, Management