Regulatory Affairs Manager
Core
Establish strategies for worldwide product approval and submission activities, directly executing submissions for the U.S. and EU, and ensuring regulatory compliance for Lung Health and Gynecologic products.
Role type
Manager-level Regulatory Affairs Lead
Builds
Regulatory submission packages and strategies for medical devices
Domain
Healthcare / Medical Devices
Required skills
Regulatory strategy development, FDA and EU MDR interaction, team leadership, cross-functional collaboration, compliance monitoring, document package coordination
Preferred skills
Medical device regulatory experience, engineering background, talent development, project prioritization
Technologies
EU MDR, FDA submission systems
Responsibilities
Oversee day-to-day functions of the Regulatory Affairs team, develop regulatory strategies for new and existing devices, lead interactions with regulatory agencies, manage team performance and development, provide oversight of advertising and promotional material reviews, coordinate document packages for submissions and audits.
Seniority
Manager, hands-on leadership with delegation