Regulatory Affairs Manager

Medtronic seeks a Regulatory Affairs Manager to oversee product approval strategies and compliance for Lung Health and Gynecologic devices. The role involves leading a regulatory team, developing submission strategies for U.S. and EU markets, and collaborating across functions to support product lifecycles.

Responsibilities

• Oversee daily operations of Lung Health and Gynecologic Regulatory Affairs team
• Develop and execute regulatory strategies for existing, new, and modified medical devices
• Lead interactions with regulatory agencies and manage submission preparation and coordination
• Manage team performance, resource planning, talent development, and succession planning
• Partner with quality, engineering, clinical, and commercial teams to ensure compliance throughout product lifecycle

Requirements

• Bachelor's degree required; advanced degree with 5+ years experience acceptable
• Minimum 7 years relevant regulatory affairs experience
• Knowledge of U.S., EU MDR, and international medical device regulations
• Experience with FDA interactions, Q-Submissions, and regulatory agency meetings
• Demonstrated ability to lead high-performing teams and develop talent
• Strong project management and cross-functional collaboration skills