We anticipate the application window for this opening will close on - 3 Oct 2026

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 continuous improvement initiatives.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. a7 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind:

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official [redacted].com email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [redacted].

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$154,400.00 - $231,600.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans