Project Manager, MDRIM & Document Mgmt.

This role leads and coordinates MDRIM (Medical Device Regulatory Information Management) and document management projects within QARA International, ensuring regulatory documentation, data, and processes meet global and regional requirements. The Project Manager drives cross‑functional execution, improves quality and compliance processes, and supports operational readiness across international markets. This position offers the opportunity to have a direct impact on regulatory compliance, inspection readiness, and the efficient lifecycle management of medical device documentation. Key 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 (Regulatory Affairs, Quality, R&D, Manufacturing, and external partners) 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. Apply Johnson & Johnson Credo values and quality principles in all project activities.

Education

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

Skills

• Required: 6–8 years of relevant experience in project management, quality, regulatory, or document management environments within a regulated industry (medical devices, pharmaceuticals, or healthcare preferred)
• Demonstrated experience managing cross‑functional, international projects
• Working knowledge of quality systems, regulatory documentation, and controlled document management processes
• Preferred: Experience supporting MDRIM, regulatory information management, or global submissions
• Familiarity with EU MDR/IVDR and global regulatory expectations
• Experience working in matrixed, global organizations
• Project management certification (e.g., PMP, PRINCE2) preferred
• Strong organizational, planning, and risk management skills
• Effective written and verbal communication skills with the ability to influence stakeholders
• Other: Language: Fluency in English required; Polish preferred
• Travel: Limited; up to 10–20% international travel may be required