Senior EU MDR Compliance Program Lead

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

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.