Global MDRIM & Documents Project Manager (Hybrid)

7815-Johnson & Johnson Poland Sp. z o.o. Legal Entity; Starachowice; Hybrid; PLN 146,000 - 235,000; Full time

Job summary

Johnson & Johnson Poland Sp. z o.o. Legal Entity in Warsaw seeks a Project Manager for MDRIM and document management within QARA International.

This hybrid role coordinates Regulatory Affairs, Quality, R&D, and Manufacturing teams to ensure compliant medical device documentation across markets. The role drives cross-functional execution, supports inspection readiness, and has a direct impact on regulatory compliance. English fluency is required; Polish preferred.

Qualifications

• Bachelor degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or related discipline.
• Master’s degree preferred.
• 6–8 years of relevant experience in project management, quality, regulatory, or document management environments.
• Experience managing cross-functional, international projects.
• Knowledge of quality systems, regulatory documentation, and controlled document management.

Responsibilities

• Lead 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 global regulations, internal quality standards, and inspection readiness expectations.
• Support continuous improvement initiatives by identifying process gaps and implementing standardized 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.
• Apply Johnson & Johnson Credo values and quality principles in all project activities.

Skills

Project management

Regulatory knowledge

Quality systems

Cross-functional coordination

Communication skills

English proficiency

Education

Bachelor’s degree

Master’s degree

Job description

Johnson & Johnson Poland Sp. z o.o. Legal Entity in Warsaw seeks a Project Manager for MDRIM and document management within QARA International.

This hybrid role coordinates Regulatory Affairs, Quality, R&D, and Manufacturing teams to ensure compliant medical device documentation across markets. The role drives cross-functional execution, supports inspection readiness, and has a direct impact on regulatory compliance. English fluency is required; Polish preferred.