Job Description

Medtronic seeks a Principal Regulatory Affairs Specialist to lead regulatory compliance and product launches for the Wound Management portfolio. The role encompasses managing regulatory submissions, ensuring compliance with FDA and EU requirements, and supporting product lifecycle activities from development through commercialization.

Responsibilities

• Prepare and manage Pre-Sub and 510(k) submissions for FDA clearance and international regulatory approvals
• Review product labeling changes and promotional materials for regulatory compliance
• Provide regulatory guidance to cross-functional teams including engineering, quality, and marketing
• Support international product registrations and coordinate with global regulatory affairs teams
• Maintain current regulatory documentation and departmental procedures reflecting evolving requirements

Requirements

• Bachelor's degree or advanced degree in relevant field
• Minimum 7 years relevant regulatory affairs experience (or 5 years with advanced degree)
• Broad knowledge of medical device regulatory lifecycle from concept to market
• Experience with 510(k) submissions and FDA interactions
• Strong understanding of promotional and advertising material regulations for medical devices
• Experience managing multiple concurrent regulatory submissions and projects

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