Senior Program Manager – EU MDR Operations Leader

Responsibilities

• Lead one of the Surgical Operating Unit’s most complex regulatory and operational programs
• Enable the EU MDR transition while maintaining global product availability with a heavy operations focus
• Provide direct leadership to a program team of four reports
• Orchestrate execution across regulatory, supply chain, operations, quality, clinical, and commercial organizations
• Integrate regulatory transition plans, global market access strategies, and operational readiness to ensure continuity of product supply across international markets
• Address complex operational challenges associated with regulatory transitions, product lifecycle decisions, and global supply continuity
• Guide prioritization, resolving cross-functional tradeoffs, and ensuring navigation of regulatory change without disruption to patients or customers
• Define and implement the EU MDR program strategy and Globalization approach aligned with regulatory requirements and business priorities
• Establish governance structures, decision frameworks, and operating mechanisms that enable effective program execution across multiple teams and regions
• Drive integrated program planning that aligns regulatory transition activities, market access planning, and operational readiness

• 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 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
• Experience supporting supply chain, manufacturing, or operational programs where regulatory, product lifecycle, or market access decisions impact product supply continuity
• Demonstrated ability to build or scale programs from concept through execution
• Demonstrated experience building and developing high-performing program or project management teams
• Ability to operate effectively in complex and evolving environments

• regulatory transition
• program management
• project management
• financial tracking
• market access strategies
• operational readiness
• supply chain management
• product lifecycle management
• governance structures
• program strategy

• leadership
• cross-functional collaboration
• stakeholder communication
• problem-solving
• mentoring
• prioritization
• decision-making
• organizational skills
• adaptability
• team building