Medtronic · 6 hours ago
Senior Regulatory Affairs Program Manager
Lafayette, Colorado, United States of America
Full-time
Onsite
Senior Level
$154K/yr - $232K/yr
5+ years expMedtronic is a leader in global healthcare technology that focuses on innovative solutions to health problems. The Senior Regulatory Affairs Program Manager will drive operational excellence in the Regulatory Affairs function, facilitating strategic discussions, managing risks, and ensuring effective execution of regulatory programs.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical Device
Responsibilities
Design, implement, and maintain advanced operating mechanisms to ensure seamless program execution and cross-functional alignment across all Regulatory Affairs programs
Establish and facilitate program-level meetings with senior leadership and key stakeholders to track progress, manage complex risks, and drive critical business decisions
Develop and manage comprehensive program calendars, communication plans, and high level stakeholder engagement strategies
Develop and manage the functional budget, including long-term forecasting, tracking, and reporting on expenditures
Ensure the optimal allocation of financial resources to support critical program objectives and key initiatives
Identify and implement significant cost reallocation opportunities without compromising quality or compliance
Lead and champion large-scale, high-impact process improvement initiatives aimed at enhancing the efficiency, quality, and effectiveness of regulatory operations
Collaborate with RA leaders and other department heads to forecast long-term resource needs and ensure appropriate staffing levels for all programs
Proactively identify and address complex resource constraints or conflicts to maintain project timelines and deliverable quality
Optimize resource utilization across a portfolio of multiple projects and initiatives
Develop, define, and implement key performance indicators (KPIs) and other sophisticated metrics to measure the success and efficiency of regulatory programs
Establish high level dashboards and reporting mechanisms to provide senior stakeholders with clear visibility into performance
Analyze complex performance data to identify strategic trends, opportunities for improvement, and areas of risk
Act as the primary liaison between the RA function and enterprise-level program initiatives
Ensure the seamless integration of enterprise-level initiatives (e.g., new technology platforms, corporate compliance programs) into the ACM RA function
Communicate enterprise-level changes to the team and manage the associated change management activities
Provide expert program management leadership for ad-hoc projects, special assignments, and new ventures
Qualification
Required
Bachelor's degree and 7+ years of regulatory program management experience, or advanced degree with 5 + years of regulatory program management experience
Experience with large-scale, enterprise-level initiatives: A background in integrating entire business units into broader corporate programs
Subject Matter Expertise: Deep knowledge of specific regulatory domains (e.g., global submissions, post-market surveillance, quality systems)
Experience implementing initiatives through effective influence management skills at multiple levels in the organization with a general understanding of medical device regulations and submissions
Technical Proficiency: Experience with regulatory information management systems (RIMS), project management software (e.g., Smartsheet, MS Project), and data visualization tools (e.g., MS Excel, Power BI)
Change Management: Demonstrated ability to lead and manage large-scale organizational change effectively
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)
Company
Medtronic
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry.
10001+ employees
H1B Sponsorship
Medtronic has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (349)
2024 (387)
2023 (291)
2022 (310)
2021 (300)
2020 (261)
Funding
Current Stage
Public CompanyTotal Funding
$18.16BKey Investors
NHS EnglandBlackstone Life SciencesTrade Capital Funding
2025-09-15Post Ipo Debt· $1.76B
2024-05-29Post Ipo Debt· $3.24B
2023-03-23Post Ipo Debt· $2B
Leadership Team
Geoffrey Martha
CEO and Chairman Of The Board Of Directors
Linnea Burman
SVP & President, Neurovascular
Recent News
2026-01-09
Beyond Bylines
2026-01-09
2026-01-08
Company data provided by crunchbase