Global MDRIM & Document Management Project Lead

Johnson Johnson; Warszawa; Hybrid; PLN 120,000 - 170,000; Full time

Job summary

Johnson & Johnson is recruiting for a Project Manager, MDRIM & Document Mgmt based in Warsaw, Poland. The role leads cross-functional MDRIM and document management projects across QARA International, ensuring regulatory documentation and processes meet global standards and inspection readiness.

The ideal candidate has 6–8 years of experience in regulated environments, strong project management skills, and familiarity with EU MDR/IVDR.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related discipline.
• 6-8 years of relevant experience in project management, quality, regulatory, or document management environments within a regulated industry.
• Demonstrated experience managing cross-functional, international projects.
• Working knowledge of quality systems, regulatory documentation, and controlled document management processes.

Responsibilities

• Lead and manage MDRIM and document management projects from initiation through completion, ensuring delivery on time, within scope, and in alignment with QARA priorities.
• Coordinate cross-functional stakeholders to align documentation and regulatory information requirements.
• Oversee planning, tracking, and reporting of project milestones, risks, issues, and dependencies.
• Ensure document management processes comply with applicable global regulations, internal quality standards, and inspection readiness expectations.
• Support continuous improvement initiatives by identifying process gaps and implementing standardized, efficient MDRIM and documentation workflows.
• Maintain project documentation, dashboards, and metrics to support transparency and leadership decision-making.
• Facilitate governance meetings, project reviews, and stakeholder communications across QARA International.

Skills

Project management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Life Sciences

Master's degree

Tools

PMP/PRINCE2

Job description

Johnson & Johnson is recruiting for a Project Manager, MDRIM & Document Mgmt based in Warsaw, Poland. The role leads cross-functional MDRIM and document management projects across QARA International, ensuring regulatory documentation and processes meet global standards and inspection readiness.

The ideal candidate has 6–8 years of experience in regulated environments, strong project management skills, and familiarity with EU MDR/IVDR.