Senior MDRIM & Document Management Specialist

Johnson & Johnson Co.; Warszawa; On-site; PLN 191,000 - 308,000; Full time

Job summary

Johnson & Johnson in Warsaw is seeking a Sr. Specialist for MDRIM & Document Management within the Regulatory Affairs Group. You will support the governance of regulatory information and controlled documentation across global markets, ensuring data integrity and compliance.

Collaborate with Regulatory Affairs, Quality, R&D, Manufacturing to support submissions and lifecycle activities, inspections, and continuous improvements. Fluency in English is required; up to 10% travel may be involved.

Qualifications

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

Responsibilities

• Manage MDRIM and controlled document management activities per quality systems and regulatory requirements.
• Ensure accuracy and integrity of regulatory information and documents in systems and repositories.
• Support creation, review, processing, approval, and maintenance of quality and regulatory documentation across 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 data quality metrics and drive timely resolution of documentation issues.
• Support regulatory submissions and registrations by ensuring required documentation is maintained and accessible.
• Contribute to inspections, audits, and compliance readiness through document control and regulatory information management.

Skills

Regulatory affairs

Quality systems

Document management

MDRIM

Cross-functional collaboration

Attention to detail

Matrixed environment

Education

Bachelor’s degree

Master’s degree preferred

Tools

Microsoft Office

Document management systems

Job description

Johnson & Johnson in Warsaw is seeking a Sr. Specialist for MDRIM & Document Management within the Regulatory Affairs Group. You will support the governance of regulatory information and controlled documentation across global markets, ensuring data integrity and compliance.

Collaborate with Regulatory Affairs, Quality, R&D, Manufacturing to support submissions and lifecycle activities, inspections, and continuous improvements. Fluency in English is required; up to 10% travel may be involved.