Regulatory Affairs Specialist

Medtronic seeks a Regulatory Affairs Specialist to support international regulatory strategies and product submissions across global markets. The role coordinates documentation, manages compliance activities, and collaborates with cross-functional teams to ensure timely market access and product lifecycle management.

Responsibilities

• Coordinate and prepare regulatory document packages for submissions, audits, and inspections
• Compile materials for global submissions, license renewals, amendments, and health authority responses
• Assess regulatory requirements and recommend submission strategies aligned with business needs and timelines
• Review regulatory, technical, quality, and labeling documentation for accuracy and consistency
• Identify regulatory risks and gaps early, escalating issues to support timely resolution

Requirements

• Bachelor's degree required
• Minimum 2 years of relevant regulatory experience
• Knowledge of U.S. FDA and international regulatory requirements for medical devices
• Familiarity with EU MDR, MDD, ISO 13485, and ISO 14971 standards
• Strong written and verbal communication skills
• Ability to manage multiple priorities and deadlines simultaneously
• RAC certification or progress toward certification preferred