Regulatory Affairs Program Manager

We anticipate the application window for this opening will close on - 19 May 2026

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the LifeThis position is located in Lafayette, CO and supports the Acute Care & Monitoring (ACM) operating unit.
The Regulatory Affairs Program Manager (RA Program Manager) provides regulatory program leadership for OEM and ACM distributed Medtronic brand products within the ACM Operating Unit. This role is responsible for planning, coordinating, and driving regulatory activities across OEM programs, while partnering closely with internal Regulatory Affairs teams to ensure global regulatory strategies and registrations are aligned, executed, and sustained throughout the product lifecycle.
Position requires to be onsite 4 days per week in our Lafayette, CO location.

         

         

Responsibilities may include the following and other duties may be assigned.

• Own and lead global regulatory strategy for OEM and ACM‑distributed Medtronic‑brand products across the full product lifecycle, including early development, clinical, commercialization, lifecycle management, and business transitions.
• Lead and coordinate regulatory programs, ensuring regulatory activities, deliverables, and timelines are aligned across internal functions and external OEM partners.
• Direct and coordinate the planning, preparation, and compilation of regulatory documentation for submissions, license renewals, and annual registrations, including support for internal audits and regulatory inspections.
• Serve as the primary regulatory point of contact and interface for OEM partners, working closely with internal Regulatory Affairs members to align strategy, roles, and execution.
• Assess and recommend changes to labeling, manufacturing, marketing, and clinical protocols to ensure global regulatory compliance and alignment with approved strategies.
• Coordinate and, as appropriate, support interactions with regulatory authorities on defined OEM product-related matters, as appropriate.
• Manage multiple regulatory programs simultaneously, prioritizing activities and risks to meet program, portfolio, and business schedules.
• Monitor, maintain, and continuously improve regulatory program tracking and control systems to enhance transparency, execution efficiency, and compliance.
• Maintain current knowledge of regulatory requirements, procedures, and standards, proactively assessing and communicating regulatory impacts to stakeholders.
• Participate in internal and external audits and inspections, providing program-level coordination and regulatory support as needed.

Must Have: Minimum Requirements

• Bachelor’s degree required
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience

 
Nice to Have
 

• An advanced degree in Regulatory Affairs or a technical field such as engineering
• 7+ years of medical device regulatory affairs experience with roles showing increasing responsibility
• Medical Device regulatory affairs program management experience
• Exceptional program/project management skills; knowledge of process and project planning best practices
• Experience leading efforts in a regulated environment
• Strong track record of leading complex initiatives requiring strong influence management skills and willingness and ability to institute change
• Strong influence management skills; ability to work cooperatively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals
• Excellent communication skills and interpersonal/team effectiveness – ability to succinctly and accurately communicate to various levels of management and employees
• Demonstrated capacity for strategic thinking, project planning and project management
• Exceptional analytical, planning, organization and time management skills to effectively execute project plans and budgets
• Strong experience with MS Project, MS Excel, MS PowerPoint, MS Word, and Smartsheet.

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.

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.

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):$120,800.00 - $181,200.00

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

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

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.