MED Medtronic Inc · Minneapolis, MN

Regulatory Affairs Specialist at MED Medtronic Inc — Minneapolis, MN

Full-timeMinneapolis, MNPosted 2026-07-31Apply on Workday
Apply at MED Medtronic Inc Let Jobeezy apply

Full job description

We anticipate the application window for this opening will close on - 22 Aug 2026

# A Day in the Life

Our Neuromodulation operating unit delivers advanced therapies for chronic pain, movement disorders, and nervous system conditions, offering SCS, DBS, and targeted drug delivery. Through proven technology, clinical evidence, and innovation, we provide personalized solutions that restore function and enhance quality of life.

Check us out on LinkedIn: Medtronic Brain Modulation and Pain Interventions

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. We’re working onsite 4 days a week at our Minnesota Rice Creek East facility to drive performance, foster an environment of belonging, and collaborate to inspire as we engineer the extraordinary. In collaboration with leading clinicians, researchers, and scientists worldwide,

Role Overview

The Regulatory Affairs Specialist develops strategies for worldwide product registration with Medtronic Geography Regulatory partners and global regulatory agencies to introduce products and changes to the market. This role involves:

  • Providing expert advice on regulatory requirements
  • Preparing submissions
  • Supporting approval activities
  • Assisting with license maintenance, including annual reports, renewals, design/manufacturing change notifications, QMS audits, and manufacturing site registrations
  • Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products.
  • Collaborate with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
  • Prepare FDA, European, and Canadian submissions for product changes to ensure timely market release approvals.
  • Review regulatory issues with the manager as necessary and support the resolution of submission issues with engineering partners, geography regulatory partners, and regulatory agencies.
  • Support regulatory compliance activities, including manufacturing site registration, audits, post-market vigilance reporting, and product recalls.
  • Provide regulatory support for currently marketed products, including reviewing labeling and changes to existing devices and documentation.
  • Provide feedback and ongoing support to product development teams for regulatory issues and questions.
  • Interact with FDA and international regulatory agencies on assigned projects/products, with significant issues reviewed with the manager.

To Be Successful in This Role

  • Medical Device Experience: Experience in the medical device industry, including exposure to Class II and/or Class III medical devices (510(k) and some PMA).
  • Regulatory Submission Expertise: Experience preparing and supporting regulatory filings to the FDA (including 510(k) and some PMA), EU MDR, and other global regulatory agencies.
  • Knowledge of Regulatory Requirements: Understanding of FDA requirements, guidance documents, EU MDR, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards.

Must Have: Minimum Requirements

  • Bachelor’s degree in a scientific discipline or equivalent
  • Minimum 2 years of regulatory affairs experience

Nice To Have

  • Experience in regulatory affairs, including conducting change assessments for Class II (510(k) devices).
  • Advanced degree in a scientific discipline (engineering, physical/biological, or health sciences).
  • Exposure to device submissions and interactions with regulatory agencies.

Physical Job Requirements

U.S. Work Authorization & Sponsorship

Recruitment Fraud Alert

# Benefits & Compensation

Salary ranges for U.S (excl. PR) locations (USD):$74,400.00 - $111,600.00

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information applies solely to candidates hired within the United States (local-market compensation and benefits will apply to others).