Regulatory Affair Specialist - Onsite

Medtronic seeks a Regulatory Affairs Specialist to support medical device regulatory submissions, compliance activities, and product lifecycle management across global markets. The role involves collaborating with cross-functional teams to facilitate product registrations and maintain regulatory compliance for implantable and minimally invasive therapies.

Responsibilities

• Prepare and support regulatory submissions for United States, European Union, Canada, and other markets
• Collaborate with engineering, quality, clinical, and manufacturing teams on regulatory requirements assessment
• Develop regulatory documentation for product registrations, renewals, and change notifications
• Review labeling, technical documentation, and design changes for regulatory impact and compliance
• Support regulatory compliance activities including site registrations, audits, vigilance reporting, and recalls

Requirements

• Bachelor's degree in scientific discipline with 2+ years regulatory affairs or medical device experience
• Experience supporting FDA-regulated medical devices, including Class II and Class III products
• Experience preparing or supporting regulatory submissions such as 510(k), PMA, or EU MDR filings
• Knowledge of FDA regulations, EU MDR requirements, ISO 13485, and ISO 14971 standards
• Proficiency with Microsoft Office applications
• Unrestricted U.S. work authorization at time of hire