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
Senior Regulatory Affairs Manager (Medical Devices)
Builds
Regulatory strategies and submission packages for medical devices
Domain
Healthcare / Medical Devices
Required skills
Regulatory strategy development, U.S. and EU regulatory compliance, FDA interaction, team leadership, cross-functional collaboration, document package coordination, labeling and marketing compliance, contingency planning
Preferred skills
New product development project leadership, advanced degree in engineering, talent development, knowledge of EU MDR, Q-Submission preparation
Technologies
None stated
Responsibilities
Develop regulatory strategies for existing, new, and modified medical devices; oversee day-to-day regulatory activities of the Stapling Regulatory Affairs team; lead interactions with regulatory agencies; provide guidance on regulatory requirements for contingency planning; partner with quality, engineering, clinical, manufacturing, and commercial teams; manage team performance and talent development; oversee regulatory reviews of advertising and promotional materials; coordinate preparation of document packages for regulatory submissions, internal audits, and inspections; recommend changes to labeling, manufacturing, marketing, and clinical protocols; monitor and improve tracking and control systems.
Seniority
Senior, hands-on leadership with delegation