Principal Regulatory Affairs Specialist

Medtronic seeks a Principal Regulatory Affairs Specialist to lead global regulatory strategies for surgical robotics consumable products across development, commercialization, and lifecycle management. The role requires a strategic individual contributor with substantial medical device experience to collaborate cross-functionally and provide regulatory subject matter expertise.

Responsibilities

• Lead and execute global regulatory strategies across product lifecycle stages
• Provide regulatory strategy input for early-stage development and pathway assessment
• Act as strategic partner to R&D, marketing, clinical, and operations teams
• Lead U.S. and EU regulatory submissions and oversee global market submissions
• Support regulatory agency interactions, audits, inspections, and corrective action activities

Requirements

• Bachelor's degree required
• Minimum 7 years relevant experience, or advanced degree with 5 years experience
• Extensive medical device regulatory affairs experience
• Hands-on experience with U.S. Class II and III devices and applicable standards
• Knowledge of EU MDR, ISO 13485, ISO 14971, and ISO 10993-1
• Experience authoring U.S. regulatory submissions (510(k), PMA, IDE)
• Direct interaction experience with regulatory authorities in U.S., EU, and global markets