Principal Project Management Specialist - Compliance PMO

Location: Lafayette, CO or Mounds View, MN

Travel: Up to 25%, primarily within the United States

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About the Role

Our medical device manufacturing client is seeking a Principal Project Management Specialist to lead complex EU Medical Device Regulation (MDR) implementation and compliance change-control projects for released products.

This role partners with Regulatory Affairs, Quality, Engineering, Operations, Supply Chain, manufacturing sites, OEMs, contract manufacturers, and external suppliers to translate compliance requirements into executable plans. You will help maintain compliant product availability and continuity of supply while driving operational readiness, risk management, and effective change execution.

Key Responsibilities

• Lead multiple complex MDR implementation and compliance change-control projects from initiation through closure.
• Align cross-functional teams on project objectives, deliverables, priorities, and execution plans.
• Develop integrated plans connecting technical deliverables, regulatory and quality requirements, supplier activities, and operational constraints.
• Partner with OEMs and contract manufacturers on MDR transition planning, including milestones, accountability, escalation paths, recovery actions, and readiness expectations.
• Coordinate changes to released products across components, suppliers, manufacturing processes, specifications, packaging, labeling, quality systems, and regulatory requirements.
• Manage project scope, schedules, budgets, resources, risks, dependencies, governance, and reporting.
• Use operational data to identify constraints and present clear options and recommendations to stakeholders.
• Lead project meetings and readiness reviews, document decisions, and maintain ownership of action items.
• Communicate project status, risks, and decisions to teams, leadership, manufacturing sites, and external partners.
• Strengthen PMO practices through lessons learned, continuous improvement, and coaching.

Required Qualifications

• Bachelor's degree with at least 7 years of relevant experience, or an advanced degree with at least 5 years. Degrees earned outside the United States must meet applicable equivalency requirements.
• Experience leading complex, interdependent projects or programs in medical devices, regulated products, manufacturing, operations, supply chain, product lifecycle management, or a comparable environment.
• Strong operational understanding of released or commercialized products and the ability to translate technical, quality, regulatory, supply, and business requirements into actionable plans.
• Direct experience leading complex technical or operational work with OEMs, contract manufacturers, or external suppliers.
• Demonstrated ability to manage integrated schedules, budgets, risks, dependencies, governance, and executive communications.
• Strong stakeholder management, negotiation, conflict-resolution, and communication skills.
• Ability to influence cross-functional teams and establish accountability without direct authority.
• Ability to work independently through ambiguity, changing priorities, and resource constraints using structured problem-solving.

Preferred Qualifications

• Experience with EU MDR implementation, regulatory remediation, compliance programs, or global released-product lifecycle management.
• Experience leading supplier transitions, manufacturing or process changes, capacity or supply-continuity initiatives, component obsolescence, quality improvement, or cost-improvement programs.
• Working knowledge of medical device quality systems, design controls, change controls, validation, risk management, configuration management, and applicable regulatory standards.
• Degree in Engineering, Operations, Supply Chain, a scientific discipline, or equivalent industry experience; an advanced technical degree or MBA is preferred.
• PMP, Lean, Six Sigma, or a comparable project management or operational excellence certification. xhyhwjd
• Strong business acumen and experience using AI-powered tools to improve analysis, productivity, communication, and decision-making.