Regulatory Affairs Manager Job at Medtronic, Minnesota

  • Medtronic
  • Minnesota

Job Description

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

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