Global Regulatory Affairs Specialist — Medical Devices

Medtronic plc; Lafayette (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Medtronic plc, a global leader in healthcare technology, seeks a Regulatory Affairs Specialist to support international regulatory strategies and submissions for medical devices. You will collaborate with Quality, Clinical, Manufacturing, and Marketing to ensure timely registrations and market access.

This on-site role may be based in North Haven, CT or Lafayette, CO, covering submissions across Asia Pacific, the Middle East and Africa, Latin America, Canada, and EMEA.

Qualifications

• Bachelor's degree required.
• Minimum of 2 years of relevant regulatory experience.
• Experience with medical device regulatory submissions and audits preferred.

Responsibilities

• Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
• Compile materials required for global submissions, license renewals, amendments, and responses to health authority inquiries.
• Assess regulatory requirements and help recommend submission strategies based on business needs, risk, and timelines.
• Support critical, complex, and time-sensitive registrations while balancing compliance and operational priorities.
• Review regulatory, technical, quality, labeling, and product documentation for completeness and accuracy.
• Manage multiple projects with deadlines, action items, and submission status.
• Identify regulatory risks, gaps, and delays early and escalate as needed.
• Communicate regulatory requirements clearly to internal and external stakeholders.
• Stay current with evolving global regulatory requirements and updates.

Skills

Regulatory compliance

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree

Job description

Medtronic plc, a global leader in healthcare technology, seeks a Regulatory Affairs Specialist to support international regulatory strategies and submissions for medical devices. You will collaborate with Quality, Clinical, Manufacturing, and Marketing to ensure timely registrations and market access.

This on-site role may be based in North Haven, CT or Lafayette, CO, covering submissions across Asia Pacific, the Middle East and Africa, Latin America, Canada, and EMEA.