Regulatory Affairs Director

Application window closes 9 Oct 2026. Position based in Mounds View, MN.

About the role

Medtronic is a global leader in healthcare technology with a mission to alleviate pain, restore health, and extend life. The Electro Physiology Technologies business unit focuses on advancing innovative solutions for cardiac rhythm disorders, operating in a fast‑paced, highly regulated environment that emphasizes quality, innovation, cross‑functional partnership, and continuous improvement. This Regulatory Affairs Director will lead regulatory strategy and execution for Cardiovascular Diagnostics & Services (CDS) and Patient Care Services (PCS) within the Electrophysiology Therapies (EPT) Operating Unit, directing submission activities, supporting compliance, and guiding regulatory interactions for global approvals, registrations, audits, and inspections.

Responsibilities

• Direct or perform coordination and preparation of document packages for regulatory submissions for CDS/PCS, internal audits, and inspections.
• Lead or compile all materials required in submissions, license renewals, and annual registrations.
• Recommend changes for labeling (indications), manufacturing, marketing, and clinical protocol to support regulatory compliance.
• Monitor and improve tracking and control systems.
• Keep abreast of regulatory procedures and changes.
• Direct interaction with regulatory agencies on defined matters, as applicable.
• Recommend strategies for the earliest possible clearance or approval of hardware devices and software as a medical device.
• Provide motivational leadership for the team.
• Provide thought and technical leadership to all areas of the business.
• Drive continuous improvement initiatives through creative problem solving, process innovation, and executive sponsorship.
• Manage performance, employee development, and departmental priorities through direct and/or indirect reports.
• Determine supervisory relationships and create strategic workforce staffing plans to achieve business results.
• Authorize hiring, promotion, reward, and other people decisions within the area of responsibility.
• Lead the development of strategy for the CDS/PCS teams and ensure alignment to company aims and objectives.
• Make large business decisions and some strategic decisions within the function.
• Influence outcomes that may affect financial performance, employees, or the public