Regulatory Affairs Program Manager

Medtronic • Lafayette, CO

7d • Onsite

About The Position

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. This 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.

Requirements

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

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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
• Simple Steps (global well-being program)
• 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)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal