Global MDRIM & Documentation Project Manager

Antler Co; Vlaanderen; Hybride; EUR 33 000 - 54 000; Plein temps

Résumé du poste

Johnson & Johnson is hiring a Project Manager for MDRIM & Document Management, based in Warsaw with hybrid options in New Cairo and Diegem. The role drives cross-functional execution across regulatory information management, quality systems, and document governance in a global context.

Requires 6–8 years of experience in regulated industries, strong international collaboration, and knowledge of EU MDR/IVDR. English required; Polish preferred. Up to 10–20% travel.

Qualifications

• Bachelor’s degree required in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related discipline.
• Master’s degree preferred.

Responsabilités

• 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 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.

Connaissances

Cross-functional collaboration

International project management

Quality systems knowledge

Regulatory documentation

Communication skills

Formation

Bachelor’s degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or related field

Master’s degree preferred

Description du poste

Johnson & Johnson is hiring a Project Manager for MDRIM & Document Management, based in Warsaw with hybrid options in New Cairo and Diegem. The role drives cross-functional execution across regulatory information management, quality systems, and document governance in a global context.

Requires 6–8 years of experience in regulated industries, strong international collaboration, and knowledge of EU MDR/IVDR. English required; Polish preferred. Up to 10–20% travel.