Senior Program Manager – EU MDR Operations Leader

Jobtailor; Colorado; On-site; USD 140,000 - 190,000; Full time

Job summary

Jobtailor seeks a senior Program Manager to lead one of its major regulatory and operational initiatives in the medical device space. The role focuses on guiding EU MDR transition, ensuring global product availability, and coordinating across regulatory, supply chain, and operations teams.

The candidate will manage a four-person program team, drive governance structures, and develop a globalization strategy aligned with business priorities, while navigating complex regulatory changes with

Qualifications

• Bachelor’s degree with 7+ years of relevant experience, or advanced degree with 5+ years.
• 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 in medical device, life sciences, or other regulated industries.
• Experience supporting supply chain, manufacturing, or operational programs affecting product supply continuity.

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, 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.

Skills

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

Education

Bachelor's degree

Advanced degree

Job description

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

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 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

Hard Skills

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

Soft Skills

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