Regulatory Affairs Specialist - Medical Devices, Global Impact

Medtronic plc; Lafayette (CO); On-site; USD 74,000 - 112,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

401(k) with company match

Paid time off

Job summary

Medtronic plc is seeking a Regulatory Affairs Specialist within the Advanced Energy Operating Unit in the United States. You will support regulatory documentation, assess impacts of product changes, and maintain regulatory systems to ensure global compliance.

You will partner with cross-functional teams, contribute to submissions, and stay current on regulations. The role requires at least 2 years of relevant experience or advanced degree with related experience.

Qualifications

• Bachelor’s degree required; regulatory experience is preferred.
• Experience with U.S. FDA and international regulatory requirements for medical devices.
• Familiarity with EU MDR/MDD, ISO 13485, ISO 14971.
• Experience supporting regulatory submissions, audits, or inspections.
• Strong written and verbal communication, and organization.

Responsibilities

• Prepare regulatory documentation across product lifecycle.
• Assess regulatory impact of design, labeling, manufacturing changes.
• Coordinate submissions, renewals, registrations, and filings.
• Support audits and interactions with regulatory authorities.
• Collaborate with cross-functional teams to address regulatory needs.
• Monitor regulatory developments and ensure compliance.

Skills

Regulatory knowledge

FDA/regulatory experience

Regulatory submissions

Written & verbal communication

Cross-functional collaboration

Organizational skills

Notified Bodies experience

RAC certification progress

Education

Bachelor’s degree

Job description

Medtronic plc is seeking a Regulatory Affairs Specialist within the Advanced Energy Operating Unit in the United States. You will support regulatory documentation, assess impacts of product changes, and maintain regulatory systems to ensure global compliance.

You will partner with cross-functional teams, contribute to submissions, and stay current on regulations. The role requires at least 2 years of relevant experience or advanced degree with related experience.