Senior Manager, Regulatory Operations and Excellence

Onsite

Lafayette, Colorado, United States of America

Full time

R70947

We anticipate the application window for this opening will close on - 3 Oct 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 Acute Care & Monitoring (ACM) Regulatory Affairs (RA) organization supports a global portfolio of monitoring, diagnostic, and patient care technologies used across the continuum of care. The function is responsible for enabling regulatory compliance, operational excellence, and product lifecycle support through the development of scalable processes, systems, and governance frameworks that support regulatory activities worldwide.

This role is part of the ACM Regulatory Affairs leadership team and provides leadership across Regulatory Operations, Regulatory Compliance, and Technical Communications. The position oversees critical capabilities including regulatory systems and processes, global compliance programs, Unique Device Identification (UDI), product labeling, Instructions for Use (IFU) management, and digital transformation initiatives that enable a high-performing regulatory organization.

This is an onsite position based at the Lafayette, Colorado campus.

The Senior Manager, Regulatory Operations and Excellence leads a multidisciplinary team responsible for the operational infrastructure, compliance programs, and technical communication processes that enable regulatory success across the ACM portfolio. This leader partners with Regulatory Affairs and cross-functional stakeholders to advance operational excellence, drive process automation and digital transformation, maintain global regulatory compliance, and ensure effective development and management of product labeling and documentation throughout the product lifecycle.

** Primary Responsibilities*
* + Lead Regulatory Operations, Regulatory Compliance, and Technical Communications teams supporting the ACM product portfolio.

+ Develop and execute a strategic roadmap for regulatory systems, processes, tools, and operational capabilities that improve organizational effectiveness and scalability.

+ Drive operational excellence initiatives by simplifying workflows, reducing manual activities, implementing automation solutions, and establishing best practices across the Regulatory Affairs organization.

+ Establish and maintain operational metrics, dashboards, and performance measures to provide visibility into regulatory performance, compliance status, and organizational effectiveness.

+ Oversee global regulatory compliance programs, including UDI and EUDAMED data management, audit readiness activities, inspection support, corrective action follow-up, and Notified Body interactions.

+ Provide operational leadership for product labeling and technical communications activities, including IFU development, translation, publication, content management, and eIFU implementation.

+ Partner with Regulatory Affairs leaders and cross-functional stakeholders to communicate program timelines, risks, compliance requirements, and operational priorities across the product lifecycle.

+ Lead, develop, and coach a team of program managers, regulatory specialists, and technical communications professionals while aligning resources to business priorities and organizational objectives.

** Required Qualifications*
* + Bachelor's degree in…