We anticipate the application window for this opening will close on - 8 Sep 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

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.

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 role is based in Mounds View, MN.

The Regulatory Operations Manager leads a team responsible for regulatory submission publishing, product lifecycle management, master data administration, change control support, audit readiness, and other regulatory activities. This role combines operational expertise with strategic leadership to drive efficiency, quality compliance, and team development in global regulatory processes. 

Key Responsibilities 

Team Leadership and Development: 

• Prioritize strategic and departmental initiatives, define performance goals and objectives, conduct performance reviews, and hold regular 1:1s to guide employee development and performance management. 

• Foster a culture of collaboration, accountability, and continuous improvement within the team. 

• Collaborate with Regulatory peers within our function and across other Operating Units (OUs) to support and drive the successful implementation of new initiatives and ensure business continuity. 

Regulatory Operations: 

• Oversee the preparation, compilation, and publishing of regulatory submissions, including license renewals and annual registrations, ensuring compliance with global standards. 

• Ensure accurate and efficient management of product lifecycle data and master data systems to support regulatory and business needs. 

• Lead regulatory aspects of change control processes, ensuring timely and compliant implementation. 

• Oversee planning of submission related post-market costs of the department budget; approve spending within defined limits.  

• Represent Regulatory on Enterprise-wide initiatives, keeping senior management within our OU and those that we support informed of new developments and any issues.   

Audit Support and Compliance: 

• Support internal and external audits by ensuring documentation, processes, and systems are audit-ready and compliant with applicable regulations and standards. 

• Maintain up-to-date knowledge of global regulatory requirements and ensure team activities align with those regulations, guidelines, and standards. 

Process Optimization and Systems Management: 

• Identify and implement process improvements to enhance efficiency and compliance in regulatory operations. 

• Optimize the use of electronic systems, templates, and reporting capabilities to streamline operations and improve outcomes.