Global Regulatory Affairs Specialist – Medical Devices

AVC Medtronic International Trading, Inc.; Mounds View (MN); On-site; USD 74,000 - 112,000; Full time

Benefits offered by this job

Health insurance

401(k) plan + employer match

Tuition assistance/reimbursement

Paid time off

Life insurance

Job summary

Medtronic plc in the United States seeks a Regulatory Affairs Specialist to lead regulatory strategies and submissions for cardiovascular devices. Based in Mounds View, MN, you will work onsite to support global product registrations and compliance with FDA and international requirements.

The role emphasizes collaboration with engineering teams and international regulatory staff, ensuring timely approvals and adherence to guidelines.

Qualifications

• Bachelor's degree or advanced degree with relevant regulatory experience.
• 2+ years regulatory affairs in medical devices preferred.
• Experience with FDA and international regulatory requirements advantageous.

Responsibilities

• Define regulatory strategy for product maintenance and existing approvals.
• Prepare regulatory submissions (FDA/Notified Body) and ensure timely approvals.
• Collaborate with engineers and international regulatory staff on changes and submissions.
• Review labeling and promotional material for regulatory compliance.
• Maintain registrations and support audits and inspections as needed.

Skills

Regulatory affairs

Medical devices

FDA submissions

Cross-functional work

Education

Bachelor's degree

Advanced degree

Job description

Medtronic plc in the United States seeks a Regulatory Affairs Specialist to lead regulatory strategies and submissions for cardiovascular devices. Based in Mounds View, MN, you will work onsite to support global product registrations and compliance with FDA and international requirements.

The role emphasizes collaboration with engineering teams and international regulatory staff, ensuring timely approvals and adherence to guidelines.