Regulatory Affairs Specialist

Location: Mounds View, Minnesota, United States of America

We anticipate the application window for this opening will close on - 18 Nov 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

The Cardiovascular Surgery Operating Unit focuses on a specialized clinical environment designed to support complex surgical procedures involving the heart and major blood vessels. The OU represents end stage treatment in the care continuum for many cardiovascular diseases, and this OU provides an intimate relationship with the Cardiac Surgeon and Cardiac OR by offering an unparalleled depth and breadth of portfolio.

Key Technologies

• Surgical heart valves
• Cardiac OR solutions (e.g., blood management, cannulae)
• Extracorporeal life support (ECLS)
• Coronary artery bypass grafting (CABG) solutions

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

This position will be based in Mounds View, MN.

The Regulatory Affairs Specialist is responsible for developing regulatory strategies, preparing U.S. and international submissions and obtaining and maintaining approval for products and therapies to markets worldwide. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of implementing these device changes.

Role and Responsibilities

Define the regulatory strategy for product maintenance for existing approved products.

Team with other operating unit regulatory personnel and international regulatory staff to provide support for new products/therapies and changes to existing products. Work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.

Prepare regulatory (e.g., FDA/Notified Body) submissions product changes, as required, to ensure timely approvals for clinical studies and market release. Review significant product submissions with manager.

Interact directly with FDA/Notified Body and indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager.

Support regulatory compliance activities, including manufacturing site registration, audits, etc., as needed.

Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.

Provide business and product information to international regulatory staffs to enable development of strategies and requirements and communicate that information to business teams.

Provide feedback and on-going support to product development teams for regulatory issues and questions.

Develop proficiency in domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.

Ensure personal understanding of all quality policy/system items that are personally applicable.

Follow all work/quality procedures to ensure quality system compliance and high-quality work.