Senior Manager, Regulatory Operations and Excellence

Medtronic; Lafayette (CO); Sur place; USD 140 000 - 190 000; Plein temps

Résumé du poste

Medtronic in Lafayette, Colorado is seeking a Senior Manager, Regulatory Operations and Excellence to lead Regulatory Operations, Regulatory Compliance, and Technical Communications for the ACM portfolio.

You will partner with Regulatory Affairs and cross-functional teams to drive operational excellence, implement automation and digital transformation, and ensure global regulatory compliance across product lifecycle, labeling, and documentation.

Qualifications

• Bachelor's degree and 7+ years in regulatory operations or related fields.
• Experience leading operational improvement initiatives in a complex, regulated industry.
• Experience implementing digital solutions and workflow optimization projects.

Responsabilités

• Lead Regulatory Operations, Regulatory Compliance, and Technical Communications teams for the ACM portfolio.
• Develop and execute a strategic roadmap for regulatory systems and operational capabilities.
• Drive automation and digital transformation to improve processes and governance.
• Establish metrics, dashboards, and reporting for regulatory performance and compliance.
• Oversee global regulatory programs including UDI, EUDAMED data management, and Notified Body interactions.
• Partner with cross-functional stakeholders to manage product lifecycle labeling and documentation.

Connaissances

Regulatory Operations Leadership

Regulatory Compliance

Process Automation

Cross-functional Leadership

Regulatory Systems

Formation

Bachelor's degree in Science, Engineering, Business Administration, or related technical discipline

Description du poste

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 Science, Engineering, Business Administration, or a related technical discipline and a minimum of 7 years of experience in regulatory operations, regulatory affairs, quality, compliance, or operational excellence with 5+ years of people leadership experience.
• Experience leading operational improvement initiatives within a complex, matrixed, and highly regulated industry.
• Experience implementing digital solutions, automation initiatives, workflow optimization programs, or business process transformation projects.
• Experience establishing operational metrics, performance dashboards, governance processes, or business reporting frameworks.
• Experience managing cross-functional programs involving multiple stakeholders, priorities, and global regulatory requirements.

Preferred Qualifications

• Knowledge of global medical device regulatory requirements, quality systems, and compliance frameworks.
• Experience leading product labeling, technical communications, publishing, documentation management, or content development functions.
• Experience supporting UDI, EUDAMED, GS1 GTIN administration, or global device data management programs.
• Knowledge of monitoring, diagnostic, or acute care medical device technologies.
• Demonstrated success building and leading high-performing teams while driving organizational change and continuo