Project Manager, Mdrim & Document Mgmt

22 сентября 2026 г.

Гибрид

Senior

Warsaw, Poland, New Cairo, Egypt, Diegem, Belgium

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Обязательное посещение офисаАнглийский обязателенНужен диплом

Описание

A Project Manager is recruited to lead MDRIM (Medical Device Regulatory Information Management) and document management projects within QARA International. The role coordinates regulatory documentation, data and processes to meet global and regional requirements, driving cross-functional execution, quality and inspection readiness. It is a hybrid position based in Warsaw, Poland, with alternate locations considered in New Cairo, Egypt and Diegem, Belgium. The role offers a direct impact on regulatory compliance and the lifecycle management of medical device documentation.

Обязанности

Lead and manage MDRIM and document management projects from initiation through completion
Coordinate cross-functional stakeholders across Regulatory Affairs, Quality, R&D, Manufacturing, and external partners
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
Support continuous improvement by identifying process gaps and implementing standardized MDRIM and documentation workflows
Maintain project documentation, dashboards, and metrics to support transparency and leadership decisions
Facilitate governance meetings, project reviews, and stakeholder communications across QARA International

Требования

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
Fluency in English required
Experience supporting MDRIM, regulatory information management, or global submissions (preferred)
Familiarity with EU MDR/IVDR and global regulatory expectations (preferred)
Experience working in matrixed, global organizations (preferred)
Project management certification such as PMP or PRINCE2 (preferred)
Strong organizational, planning, and risk management skills
Effective written and verbal communication skills with the ability to influence stakeholders
Master's degree preferred

Условия

Hybrid position based in Warsaw, Poland
Alternate hybrid locations may be considered in New Cairo, Egypt and Diegem, Belgium
Limited international travel up to 10–20% may be required
Annual bonus with set target depending on pay grade and location
Vacation days and parental leave for a minimum of 12 weeks
Bereavement, caregiver, and volunteer leave
Well-being reimbursement and programs for financial, physical, and mental health
Service anniversary and recognition awards, plus insurance plans where eligible

MDRIMDocument ManagementRegulatory AffairsQARAEU MDREU IVDRQuality SystemsPMPPRINCE2medical devices / healthcare (regulatory affairs)Cross-functional collaborationStakeholder communicationRisk management

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