Principle Project Management Specialist – MDR

Planet Pharma; Lafayette (CO); On-site; USD 140,000 - 190,000; Full time

Job summary

Planet Pharma is seeking a Principal Project Management Specialist to lead MDR implementation and compliance change-control efforts for released products. The role requires coordinating Regulatory Affairs, Quality, Engineering, and Manufacturing to translate complex requirements into executable plans.

The ideal candidate will guide cross-functional teams, manage schedules and budgets, and influence stakeholders without direct authority.

Qualifications

• Bachelor’s degree with 7+ years of relevant experience, or advanced degree with 5+ years.
• Experience leading complex, cross-functional projects in regulated environments.
• Ability to translate regulatory, quality, and business requirements into executable plans.

Responsibilities

• Lead MDR implementation and compliance change-control projects from initiation through closure.
• Coordinate cross-functional teams across Regulatory Affairs, Quality, Engineering, Operations, and Supply Chain.
• Manage scope, schedules, budgets, risks, and governance with data-driven updates to leadership.
• Influence stakeholders and communicate complex information without direct authority.

Skills

Project management

Cross-functional leadership

Regulatory affairs

Quality systems

Communication across teams

Influence without authority

Problem solving

Education

Bachelor’s degree

Advanced degree (Master/PhD)

Tools

PMP

Lean

Six Sigma

AI-powered tools

Job description

Careers that Change Lives

As a Principal Project Management Specialist within the Compliance PMO, you will lead complex EU Medical Device Regulation (MDR) implementation and compliance change-control projects for released products. You will align Regulatory Affairs, Quality, Engineering, Operations, Supply Chain, manufacturing sites, original equipment manufacturers (OEMs), contract manufacturers, and external suppliers to translate compliance requirements into executable plans.

Your work will protect compliant product availability and continuity of supply while strengthening released-product implementation, operational readiness, risk management, and change execution. This role is ideal for an experienced project leader who combines disciplined program management, operational judgment, and influence across internal and external organizations.

A Day in the Life

• Lead multiple complex MDR implementation and compliance change-control projects for released products from project initiation through closure.
• Guide cross-functional teams across Regulatory Affairs, Quality, Engineering, Manufacturing, Operations, Supply Chain Planning, Supplier Quality, and other partners to align execution with compliance and business objectives.
• Develop integrated plans connecting technical deliverables, regulatory and quality requirements, supplier activities, operational constraints
• Collaborate with OEMs for MDR Transition planning by establishing deliverables, milestones, decision rights, escalation paths, recovery actions, and readiness expectations.
• Coordinate released-product changes across components, suppliers, manufacturing processes, specifications, packaging, labeling, quality systems, and regulatory requirements.
• Manage scope, schedules, budgets, resources, risks, assumptions, dependencies, decisions, governance, and reporting; use operational data to identify constraints and elevate issues with clear options and recommendations.
• Lead meetings and readiness reviews, maintain decisions and action ownership, and communicate concise updates to teams, leaders, sites, and external partners.
• Advance portfolio priorities and PMO practices through lessons learned, data-driven insights, coaching, and influence without direct authority.

This position is located in Lafayette, CO. Travel up to 25%, primarily in US.

Qualifications – To thrive in this role, you must have:

• Bachelor’s degree and a minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years. Degrees earned outside the United States must meet applicable equivalency requirements.
• Demonstrated experience leading complex, interdependent cross-functional projects or programs in medical devices, regulated products, manufacturing, operations, supply chain, product lifecycle management, or a comparable environment.
• Strong operational knowledge of released or commercialized products, including translating technical, quality, regulatory, supply, and business requirements into executable plans.
• Direct experience leading complex technical or operational work with OEMs, contract manufacturers, or external suppliers.
• Experience managing integrated schedules, budgets, risks, dependencies, governance, executive communications, and cross-functional decisions.
• Ability to influence, establish accountability, negotiate, resolve conflict, and communicate complex information across teams, leaders, executives, and external organizations without direct authority.
• Ability to work independently through ambiguity, changing priorities, resource constraints, and issues requiring structured investigation and practical problem solving.

Nice to Have

• 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 continuity initiatives, component obsolescence, quality improvement, remediation, or cost-improvement programs for commercialized products.
• Working knowledge of medical-device quality systems, design and change controls, validation, risk and 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 comparable project-management or operational-excellence certification.
• Business acumen and experience using AI-powered tools to improve analysis, productivity, communication, decisions, or business outcomes.