EU MDR Compliance Program Lead (PMO)

ATR International; Lafayette (CO); On-site; USD 110,000 - 150,000; Full time

Job summary

ATR International is seeking a Principal Project Management Specialist in Lafayette, CO or Mounds View, MN to lead complex EU MDR implementation and compliance projects for released products. Travel up to 25% within the United States.

You will partner with Regulatory Affairs, Quality, Engineering, Operations, and external suppliers to translate regulatory requirements into executable plans while maintaining product availability and supply continuity.

Qualifications

• Bachelor's degree or higher required; 5+ years if advanced degree
• Experience leading complex, interdependent projects in medical devices or regulated products
• Ability to translate regulatory, quality, and business requirements into actionable plans
• Direct experience with OEMs, contract manufacturers, or external suppliers
• Strong schedules, budgets, risks, dependencies, and executive communications
• Proven ability to influence cross-functional teams and drive accountability

Responsibilities

• Lead multiple MDR implementation and compliance projects from initiation to closure
• Align cross-functional teams on objectives, deliverables, priorities and plans
• Develop integrated plans linking technical deliverables with regulatory and quality requirements
• Coordinate MDR transition planning with OEMs and contract manufacturers
• Manage changes to released products across components, processes, and quality systems
• Oversee schedules, budgets, risks, dependencies and governance
• Use data to identify constraints and present options to stakeholders
• Lead readiness reviews, document decisions and own action items
• Communicate status and decisions to teams, leadership, and partners
• Strengthen PMO practices through lessons learned and continuous improvement

Skills

Stakeholder management

Cross-functional leadership

Communication

Structured problem-solving

Negotiation

Influence without authority

Education

Bachelor's degree

Advanced degree

Job description

ATR International is seeking a Principal Project Management Specialist in Lafayette, CO or Mounds View, MN to lead complex EU MDR implementation and compliance projects for released products. Travel up to 25% within the United States.

You will partner with Regulatory Affairs, Quality, Engineering, Operations, and external suppliers to translate regulatory requirements into executable plans while maintaining product availability and supply continuity.