Project Manager, MDRIM & Document Mgmt.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: Professional All Job Posting Locations: Diegem, Flemish Brabant, Belgium, New Cairo, Cairo, Egypt, Warsaw, Masovian, Poland Job Description: 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. Qualifications 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. </spa