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Job Function:
Regulatory Affairs GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Cairo, EgyptJob 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.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
#LI-Hybrid
#DePuySynthesCareers
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, TeamworkSkills Required
- 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 within a regulated industry
- Experience managing cross-functional, international projects
- Working knowledge of quality systems, regulatory documentation, and controlled document management processes
- Master's degree
- 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 such as PMP or PRINCE2
- Strong organizational, planning, and risk management skills
- Effective written and verbal communication skills with ability to influence stakeholders
- Fluency in English
- Polish language proficiency
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
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