Regulatory Affairs Program Manager

1w1 week ago

Medtronic

Lafayette, US · Full-time · $120,800 – $181,200

About this role

At Medtronic, begin a life-long career of exploration and innovation while championing healthcare access and equity for all. The Regulatory Affairs Program Manager provides regulatory program leadership for OEM and ACM distributed Medtronic brand products within the Acute Care & Monitoring operating unit. This role plans, coordinates, and drives regulatory activities across OEM programs.

Lead global regulatory strategy across the full product lifecycle, from early development through commercialization and business transitions. Coordinate regulatory programs, ensuring alignment of activities, deliverables, and timelines across internal functions and external OEM partners. Direct preparation and compilation of regulatory documentation for submissions, renewals, and registrations.

Serve as the primary regulatory point of contact for OEM partners, partnering closely with internal Regulatory Affairs teams. Position requires onsite presence 4 days per week in Lafayette, CO, fostering collaboration in a connected, compassionate world. Assess changes to labeling, manufacturing, and protocols to ensure global compliance.

Manage multiple regulatory programs simultaneously, prioritizing risks to meet business schedules. Monitor and improve regulatory program tracking systems for enhanced transparency and efficiency. Participate in audits and inspections, maintaining knowledge of regulatory requirements to communicate impacts to stakeholders.

Requirements

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

Responsibilities

Own and lead global regulatory strategy for OEM and ACM-distributed Medtronic-brand products across the full product lifecycle
Lead and coordinate regulatory programs, ensuring alignment across internal functions and external OEM partners
Direct and coordinate planning, preparation, and compilation of regulatory documentation for submissions, license renewals, and annual registrations
Serve as the primary regulatory point of contact and interface for OEM partners
Assess and recommend changes to labeling, manufacturing, marketing, and clinical protocols to ensure global regulatory compliance
Coordinate and support interactions with regulatory authorities on OEM product-related matters
Manage multiple regulatory programs simultaneously, prioritizing activities and risks
Monitor, maintain, and continuously improve regulatory program tracking and control systems