Senior MDRIM & Document Governance Specialist

7815-Johnson & Johnson Poland Sp. z o.o. Legal Entity; Poland; Sur place; PLN 185 000 - 299 000; Plein temps

Résumé du poste

Johnson & Johnson Poland is seeking a Sr. Specialist, MDRIM & Document Management in Warsaw to support regulatory information governance and controlled documentation.

You will collaborate with Regulatory Affairs, Quality, R&D and Manufacturing to ensure data integrity, document compliance, and timely submissions across international markets.

English fluency is required; Polish is an advantage. 4–6 years in regulatory affairs or document management, with MDRIM experience and knowledge of EU MDR.

Qualifications

• Bachelor's degree required in Life Sciences, Engineering, Quality, Regulatory Affairs, Information Management, or a related discipline.
• Master's degree preferred.

Responsabilités

• Manage MDRIM and controlled document management activities in accordance with quality systems, regulatory requirements, and internal procedures.
• Ensure accuracy, completeness, and integrity of regulatory information and documents within applicable systems.
• Support creation, review, processing, approval, and maintenance of quality and regulatory documentation throughout the product lifecycle.
• Collaborate with Regulatory Affairs, Quality, R&D, Manufacturing, and other stakeholders to meet documentation and regulatory information requirements.
• Provide subject matter expertise on document management processes, data governance, workflows, and system requirements.
• Monitor document and data quality metrics, identify discrepancies, and drive timely remediation.
• Support regulatory submissions and registrations by ensuring required documentation and data are maintained and accessible.
• Contribute to inspections, audits, and compliance readiness through effective document control.

Connaissances

MDRIM

Document management

Regulatory knowledge

Cross-functional collaboration

Attention to detail

Formation

Bachelor's degree

Master's degree

Outils

Microsoft Office

Document management tools

Description du poste

Johnson & Johnson Poland is seeking a Sr. Specialist, MDRIM & Document Management in Warsaw to support regulatory information governance and controlled documentation.

You will collaborate with Regulatory Affairs, Quality, R&D and Manufacturing to ensure data integrity, document compliance, and timely submissions across international markets.

English fluency is required; Polish is an advantage. 4–6 years in regulatory affairs or document management, with MDRIM experience and knowledge of EU MDR.