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)