Senior Regulatory Affairs Program Manager

Medtronic • Lafayette, CO

6d

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. A Day in the Life As a Senior Regulatory Affairs Program Manager, you will be the strategic linchpin that drives operational excellence across the different arms of the RA function within the Acute Care & Monitoring (ACM) operating unit. Your day will be a dynamic mix of strategic planning and tactical execution. A significant portion of your day will involve facilitating program-level meetings with leadership, where you will use your expertise to guide strategic discussions, manage through risks, and drive critical decisions to ensure the functional commitments are met. You will also dedicate time to analyzing and interpreting complex performance data, balancing resource demand across the function, managing the budget forecast relative to AOP, and driving process/systems improvement initiatives. Your role is a blend of a forward-thinking strategist, a hands-on problem-solver, and a collaborative leader, all working to ensure our regulatory affairs function operates at the highest level of efficiency and effectiveness.

Requirements

• Bachelor's degree and 7+ years of regulatory program management experience, or advanced degree with 5 + years of regulatory program management experience.

Nice To Haves

• 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.

Responsibilities

• Operating Mechanisms: 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.
• Budget Management: 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.
• Process Improvement Initiatives: Lead and champion large-scale, high-impact process improvement initiatives aimed at enhancing the efficiency, quality, and effectiveness of regulatory operations.
• Resource Management: 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.
• Performance Metrics Development and Execution: 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.
• Integration of Enterprise Initiatives: 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.
• Other Business Initiatives: Provide expert program management leadership for ad-hoc projects, special assignments, and new ventures.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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).
• 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).

What This Job Offers

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