Senior PD Program Manager – EU MDR Leader

Role Overview

• Define and implement the EU MDR Globalization strategy aligned with regulatory requirements and business priorities
• Establish governance structures, decision frameworks, and operating mechanisms to support effective program execution
• Ensure alignment and coordination across MDR program workstreams
• Lead and develop a team responsible for key MDR transition workstreams, ensuring alignment, accountability, and coordinated execution across the program
• Drive alignment across cross-functional teams and manage interdependencies across program workstreams
• Provide coaching and leadership to strengthen program management practices across the team
• Develop and maintain integrated program plans including milestones, dependencies, and risk mitigation strategies
• Monitor program progress and proactively address risks, issues, and constraints
• Provide clear recommendations on prioritization, trade-offs, and execution adjustments as conditions evolve
• Lead multi-year resource planning including staffing, tools, and operational capabilities
• Manage program budgets and track financial performance against program plans
• Partner with cross-functional leaders to maintain alignment on program priorities and regulatory commitments
• Provide clear, consistent program reporting including dashboards, risks, and leadership updates
• Define and monitor key performance indicators to assess program health and execution effectiveness
• Identify opportunities to simplify processes, improve scalability, and strengthen program governance

Requirements

• Bachelor’s degree with a minimum of 7 years of relevant experience OR advanced degree with a minimum of 5 years of relevant experience
• 5+ years leading complex cross-functional programs in a matrixed environment
• 5+ years managing multiple concurrent projects or programs of increasing complexity
• 5+ years of experience managing program budgets or financial tracking
• 5+ years leading stakeholder communications across multiple organizational levels
• 5+ years directly managing or mentoring project managers or program team members
• Experience working in the medical device, life sciences, or other regulated industry
• Working knowledge of global medical device regulatory frameworks
• Demonstrated ability to build or scale programs from concept through execution
• Ability to operate effectively in complex and evolving environments

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)