Regulatory Affairs Manager
Full-time
Medtronic
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
Vacancy posted 2 days ago
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