Regulatory Information & Document Mgmt Lead

Brighter Signals; Warszawa; On-site; PLN 185,000 - 299,000; Full time

Job summary

Johnson & Johnson, DePuy Synthes, located in Warsaw, Poland, seeks a Sr. Specialist MDRIM & Document Management to govern regulatory information and controlled documents across international markets.

You will partner with Regulatory Affairs, Quality, R&D, and Manufacturing to support submissions, lifecycle activities, inspections, and continuous process improvements while ensuring data integrity and compliance.

Qualifications

• Bachelor's degree in a life sciences, engineering, quality or regulatory field.
• Master's degree preferred for advanced roles.
• 4–6 years in regulatory affairs or related functions in regulated industries.

Responsibilities

• Manage MDRIM and controlled document management per quality systems and regulatory requirements.
• Ensure accuracy and integrity of regulatory information and documents across systems.
• Create, review, approve, and maintain quality and regulatory documentation throughout product lifecycles.
• Collaborate with Regulatory Affairs, Quality, R&D and Manufacturing to meet documentation needs.
• Provide subject matter expertise on document management processes and data governance.
• Monitor data quality metrics and drive timely issue resolution.
• Support regulatory submissions and registrations; prepare for inspections and audits.
• Contribute to continuous improvement of MDRIM and document management processes.

Skills

Regulatory affairs

Quality systems

Document management

MDRIM

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs, Information Management, or a related discipline

Master's degree preferred

Tools

Microsoft Office

Job description

Johnson & Johnson, DePuy Synthes, located in Warsaw, Poland, seeks a Sr. Specialist MDRIM & Document Management to govern regulatory information and controlled documents across international markets.

You will partner with Regulatory Affairs, Quality, R&D, and Manufacturing to support submissions, lifecycle activities, inspections, and continuous process improvements while ensuring data integrity and compliance.