Regulatory Affairs Manager
Core
Establish strategies for worldwide product approval and submission activities, directly executing submissions focused on the U.S. and EU, and ensuring regulatory compliance for products within the Surgical Operating Unit.
Role type
Manager-level Regulatory Affairs Manager
Builds
Regulatory strategies and submission packages for medical devices
Domain
Medical Devices / Healthcare Technology
Required skills
Regulatory strategy development, U.S. and EU regulatory compliance, FDA and international agency interaction, cross-functional collaboration, team leadership and performance management, document package coordination, labeling and marketing compliance, process improvement
Preferred skills
Medical device regulatory affairs experience, new product development project leadership, engineering or advanced degree, talent development, knowledge of EU MDR and risk classification standards, Q-Submission preparation
Technologies
Regulatory submission systems, document management tools
Responsibilities
Serve as regulatory lead for new product development projects, oversee day-to-day regulatory activities of the team, develop regulatory strategies for existing and new medical devices, collaborate with external regulatory authorities, lead interactions with regulatory agencies, provide guidance on regulatory requirements for contingency planning, partner with quality and engineering teams, manage team performance and talent development, oversee regulatory reviews of advertising materials, conduct performance evaluations, coordinate document packages for submissions and audits, recommend changes to labeling and protocols, monitor tracking and control systems
Seniority
Manager, hands-on leadership with team management