Project Manager, MDRIM & Document Mgmt.

Overview

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Tätigkeitsbereich:Regulatory Affairs Group

Unterfunktion Der Tätigkeit:Regulatory Affairs

Tätigkeitskategorie:Professional

Alle Standorte Für Stellenangebote:Cairo, Egypt

Jobbeschreibung: DePuy Synthes is recruiting for a(n) Project Manager, MDRIM & Document Mgmt , this Hybrid position will be in Warsaw, Poland. Alternate Hybrid locations may be considered at New Cairo, Egypt and Diegem, Belgium.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Warsaw, Poland - Requisition Number: 097944

New Cairo, Egypt - Requisition Number: 099996

Diegem, Belgium - Requisition Number: 097944

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Overview

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.