Senior Manager, Regulatory Operations and Excellence

Medtronic; Louisiana (MO); On-site; USD 154,000 - 232,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Tuition assistance

Job summary

Medtronic seeks a Senior Manager, Regulatory Operations and Excellence, onsite at the Lafayette, Colorado campus. You will lead Regulatory Operations, Compliance, and Technical Communications, shaping regulatory systems and lifecycle processes for the ACM portfolio.

You will drive operational excellence, implement automation, and manage labeling/documentation across global programs, partnering with cross-functional leaders to ensure compliant product lifecycle management.

Qualifications

• Bachelor’s degree in Science, Engineering, Business Administration, or related technical discipline; 7+ years in regulatory ops/affairs, plus 5+ years in people leadership.
• Experience leading operational improvement initiatives within a complex, regulated industry.
• Experience implementing digital solutions, automation, or process transformation projects.
• Experience establishing operational metrics, dashboards, governance, or reporting frameworks.
• Experience managing cross-functional programs with global regulatory requirements.

Responsibilities

• Lead Regulatory Operations, Regulatory Compliance, and Technical Communications teams for the ACM product portfolio.
• Develop and execute a strategic roadmap for regulatory systems, processes, tools, and operational capabilities.
• Drive operational excellence by simplifying workflows, automating tasks, and adopting best practices.
• Establish metrics, dashboards, and governance to monitor regulatory performance and compliance.
• Oversee global regulatory compliance programs including UDI and EUDAMED data management.
• Provide leadership for product labeling and technical communications, including IFU management.
• Collaborate with stakeholders to communicate timelines, risks, and priorities across the lifecycle.
• Coach and develop a high-performing team of program managers and regulatory experts.

Skills

Regulatory Ops

Regulatory Affairs

Leadership

Process Improvement

Digital Transformation

Cross-functional Leadership

Project Management

Regulatory Systems

Education

Bachelor's degree in Science/Engineering/Business

Tools

Regulatory Systems

Job description

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 continuous improvement initiatives.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 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 @medtronic.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 [e-mail].

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 pertain 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, andSimple 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), andCapital 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

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.