Global Regulatory Affairs Specialist - Medical Devices

Regulatory Jobs; Minneapolis (MN); 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 in Minnesota is seeking a Regulatory Affairs Specialist to support regulatory strategy, submissions, approvals, and compliance for medical devices marketed globally. This onsite role collaborates with cross-functional teams to maintain product registrations and ensure regulatory compliance across markets.

Based at Medtronic’s Rice Creek East campus with a four-day in-office schedule, you will prepare submissions (FDA/EU), review labeling, and advise product teams throughout the

Qualifications

• Bachelor's degree in a scientific discipline and 2+ years of regulatory affairs experience or related roles.
• Experience with medical devices regulated under FDA requirements (Class II/III).
• Experience preparing or supporting regulatory submissions (510(k), PMA, EU MDR, or international filings).
• Knowledge of FDA/EU MDR ISO 13485 and ISO 14971 standards.
• Proficiency with Microsoft Office applications.

Responsibilities

• Prepare and support regulatory submissions for the US, EU, Canada, and other markets.
• Collaborate with engineering, quality, clinical, and manufacturing teams on regulatory requirements for changes/new products.
• Develop regulatory documentation to support registrations, renewals, annual reports, and change notifications.
• Review labeling, technical docs, and design changes for regulatory impact.
• Support interactions with regulatory authorities and respond to inquiries under guidance.
• Partner with global regulatory teams to obtain and maintain registrations.

Skills

Regulatory knowledge

Regulatory submissions

FDA regulations

MS Office

Education

Bachelor's degree in a scientific discipline

Advanced degree in engineering or health sciences

Job description

Medtronic in Minnesota is seeking a Regulatory Affairs Specialist to support regulatory strategy, submissions, approvals, and compliance for medical devices marketed globally. This onsite role collaborates with cross-functional teams to maintain product registrations and ensure regulatory compliance across markets.

Based at Medtronic’s Rice Creek East campus with a four-day in-office schedule, you will prepare submissions (FDA/EU), review labeling, and advise product teams throughout the