Regulatory Affairs Director

Medtronic · Mounds View, MN

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RegulatoryFull-time$194k–$292kCompany career page

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Role summary

Medtronic seeks a Regulatory Affairs Director to lead regulatory strategy and execution for cardiovascular diagnostics and electrophysiology services. The role combines regulatory expertise with people leadership, overseeing submissions, compliance, and agency interactions while managing teams and shaping long-term regulatory strategies.

What they're looking for

Bachelor's degree required; advanced degree acceptable with adjusted experience
10+ years medical device regulatory affairs experience with 7+ years management
Experience with complex regulatory environments and global submissions
Demonstrated ability to lead and develop teams
Strong independent judgment and strategic thinking capabilities
Knowledge of device labeling, manufacturing, and clinical protocol regulations

What you'll be doing

Direct preparation of regulatory submission packages, license renewals, and registration materials
Lead interactions with regulatory agencies on approvals, audits, and inspections
Recommend strategies for timely clearance or approval of hardware and software medical devices
Manage performance, development, and departmental priorities for direct and indirect reports
Drive continuous improvement initiatives and develop long-term regulatory strategies aligned with business objectives

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Date posted1 day ago

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