Regulatory Affairs Program Manager

About the role

The Regulatory Affairs Program Manager will support the Global Regulatory Services team and be responsible for managing large-scale regulatory programs across multiple medical device businesses. This role requires strong program and project management experience, cross-functional leadership, and the ability to drive complex initiatives from planning through execution.

Responsibilities

• Lead large-scale regulatory programs spanning multiple functional areas and business units.
• Manage the execution of projects and programs in accordance with the organization's program management methodology.
• Develop, prioritize, and manage project plans, budgets, timelines, and methodologies.
• Define project resources, milestones, deliverables, and lead cross-functional teams to achieve program goals.
• Take ownership of multiple related projects that collectively comprise a program.
• Lead complex and/or critical programs, including Extended Producer Responsibility (EPR) initiatives.
• Establish, review, and own program charters while partnering with program sponsors for approvals.
• Monitor program progress, performance, budgets, timelines, and overall program health.
• Re-evaluate program direction based on project status and business objectives.
• Identify risks, resolve program issues, and minimize project delays.
• Build and manage relationships across business units and project teams.
• Support and mentor local Program Managers in implementing standardized processes.
• Coordinate with the Corporate PMO to manage implementation schedules and budgets.
• Develop sustainable processes and best practices across business locations.
• Lead meetings, prepare presentations, and provide regular status updates to senior leadership.
• Provide training, implementation planning, and ongoing support to program participants.
• Evaluate external consultants to optimize project costs and business value.

Requirements

• Minimum 5 years of Program/Project Management experience.
• Experience managing large-scale cross-functional programs.
• Experience developing project plans, budgets, timelines, and resource allocation.
• Experience leading cross-functional teams and managing multiple projects simultaneously.

Qualifications

• Bachelor of Science required.
• Background in Program/Project Management.
• Experience within Regulatory Affairs, Medical Device, or other regulated industries preferred.
• Strong leadership, communication, and stakeholder management skills.
• Experience working with Project Management Office (PMO) methodologies.

Benefits

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Location: Maple Grove, MN 55311
Duration: 12 Months
Work Arrangement: Onsite