Project Manager, MDRIM & Document Mgmt.

Johnson Johnson; Warszawa; Hybrid; PLN 120,000 - 170,000; Full time

Job summary

Johnson & Johnson is recruiting for a Project Manager, MDRIM & Document Mgmt based in Warsaw, Poland. The role leads cross-functional MDRIM and document management projects across QARA International, ensuring regulatory documentation and processes meet global standards and inspection readiness.

The ideal candidate has 6–8 years of experience in regulated environments, strong project management skills, and familiarity with EU MDR/IVDR.

Qualifications

• 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.

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 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.

Skills

Project management

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Life Sciences

Master's degree

Tools

PMP/PRINCE2

Job description

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:

Job Sub Function:

Job Category:

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.
• 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 compan