EU MDR Site Lead & Manufacturing Project Manager

Planet Pharma; Warsaw (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Planet Pharma seeks an EU MDR Manufacturing Site Lead / Project Manager / Manufacturing Engineer to oversee and manage all EU MDR implementation activities at a designated manufacturing site. This site-based role serves as the primary liaison between the Spine EU MDR Program team and local Manufacturing, Quality, Engineering, and Operations leaders to ensure timely, compliant MDR delivery.

Responsibilities include leading site-level execution plans, coordinating cross-functional activities,

Qualifications

• Bachelor’s degree in Engineering required.
• 7 years of relevant experience, including 5+ years in project management or site leadership roles; or advanced degree with 5 years of relevant experience and 5+ years of project or site leadership experience.

Responsibilities

• Lead and manage all Spine EU MDR implementation activities within the assigned manufacturing site.
• Own site-level execution plans and schedules, ensuring alignment with the overarching Spine EU MDR implementation timeline.
• Serve as the primary point of contact between the EU MDR Program Lead and site Manufacturing leadership.
• Coordinate site execution across Manufacturing, Quality, Engineering, Supply Chain, and Operations teams.
• Ensure site readiness and timely completion of MDR implementation deliverables, including ECO/MCO/SMECO execution, documentation updates, and system readiness.
• Track progress against milestones, identify risks or constraints, and develop mitigation plans to protect timelines.
• Escalate execution issues, capacity constraints, or dependency risks to the EU MDR Program team as needed.
• Support audits, inspections, and internal reviews by ensuring implementation activities are properly documented and traceable.
• Drive adherence to standardized MDR implementation processes while accounting for site-specific execution constraints.

Skills

Project management

Manufacturing processes

Regulatory deadlines

Education

Bachelor’s degree in Engineering

Job description

Planet Pharma seeks an EU MDR Manufacturing Site Lead / Project Manager / Manufacturing Engineer to oversee and manage all EU MDR implementation activities at a designated manufacturing site. This site-based role serves as the primary liaison between the Spine EU MDR Program team and local Manufacturing, Quality, Engineering, and Operations leaders to ensure timely, compliant MDR delivery.

Responsibilities include leading site-level execution plans, coordinating cross-functional activities,