Regulatory Affairs Specialist

Regulatory Affairs Specialist supporting medical device product development and compliance across the product lifecycle at Medtronic's Access and Instruments Operating Unit. The role involves preparing regulatory documentation, assessing product changes, maintaining compliance systems, and partnering with cross-functional teams to navigate global regulatory requirements.

Responsibilities

• Partner with multidisciplinary teams to communicate regulatory requirements and support strategy
• Assess regulatory impact of design, labeling, manufacturing, and process changes
• Prepare, review, and coordinate documentation for regulatory submissions and filings
• Support audits, inspections, and regulatory authority interactions as needed
• Monitor tracking systems and maintain regulatory documentation; stay current on applicable regulations

Requirements

• Bachelor's degree required
• Minimum 2 years regulatory experience, or advanced degree with 0 years experience
• Knowledge of U.S. FDA and international medical device regulatory requirements
• Familiarity with EU MDR, MDD, ISO 13485, and ISO 14971 standards
• Strong written and verbal communication skills
• Ability to manage multiple priorities in fast-paced environment
• Unrestricted U.S. work authorization at hire (sponsorship not available for this level)