We anticipate the application window for this opening will close on - 28 Nov 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Join the Medtronic Cardiac Ablation Solutions (CAS) regulatory affairs team of innovators who bring their worldview, unique backgrounds, and individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, and we believe that this drives healthcare forward and sets us apart as a global leader in medical technology and solutions.  Cardiac Ablation Solutions is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care, cardiac mapping, and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives of people with cardiac arrhythmias, to date CAS has transformed the lives of over 1 million patients. 

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 Associate Regulatory Affairs Specialist will work under the guidance of their manager and more senior regulatory specialists to provide support for Cardiac Ablation Solutions products. This role will include a blend of international regulatory affairs, operations, and project coordination work.  Regulatory affairs work will focus on international submission activities including maintaining regulatory approvals, renewals, registrations and tender activities and assessment of device changes for registration implications.  Regulatory operations work will involve supporting regulatory systems relating to product release, economic operator verification, registration and listing, data management and initiatives to maintain integrity of CAS regulatory information, among other activities. 

Roles and Responsibilities 

• Understanding global regulatory requirements and how to research detailed requirements. 

• Contributing to global product registration maintenance, including EU MDR Technical Documentation/MDD Technical Files.  

• Assessing device changes for registration implications and electronically notifying geographies of regulatory changes. 

• Routing regulatory documents for approvals in electronic systems, maintaining approval information, and maintaining electronic document collections. 

• Supporting requests to systems relating to product release, economic operator verification, and registration and listing. 

• Participating in preparation for internal and external regulatory audits. 

• Compiling materials required for new global product submissions, license renewals and change submissions. Monitoring, maintaining, and improving global regulatory tracking/control systems. 

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