Senior MDRIM & Document Management Specialist

Johnson & Johnson Co.; Starachowice; Vor Ort; PLN 191.000 - 308.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Vacation days

Parental leave

Zusammenfassung

Johnson & Johnson is recruiting a Sr. Specialist, MDRIM & Document Management in Warsaw, Poland. This role supports management, governance, and compliance of regulatory information and controlled documentation across international markets.

The candidate will partner with Regulatory Affairs, Quality, R&D, and Manufacturing to ensure timely submissions, lifecycle activities, and inspections, while promoting data integrity and standardization.

Qualifikationen

• Bachelor’s degree in Life Sciences, Engineering, Quality, Regulatory Affairs, Information Management, or related field; Master’s preferred.
• 4-6 years of regulatory affairs, quality systems, document management, MDRIM or related functions.

Aufgaben

• Manage MDRIM and controlled document management activities.
• Ensure accuracy and integrity of regulatory information and documents.
• Support creation, review, approval, and maintenance of quality/regulatory documents.
• Collaborate with Regulatory Affairs, Quality, R&D, Manufacturing and other stakeholders.
• Provide SME on document management processes, data governance, workflows, systems.
• Monitor data quality metrics and drive timely issue resolution.
• Support regulatory submissions and registrations.
• Assist with training and process guidance for MDRIM and document management.

Kenntnisse

Regulatory affairs

Document management

Quality systems

Cross-functional collaboration

Regulatory compliance

Ausbildung

Bachelor’s degree

Master’s degree

Tools

Microsoft Office

Document management tools

Jobbeschreibung

Johnson & Johnson is recruiting a Sr. Specialist, MDRIM & Document Management in Warsaw, Poland. This role supports management, governance, and compliance of regulatory information and controlled documentation across international markets.

The candidate will partner with Regulatory Affairs, Quality, R&D, and Manufacturing to ensure timely submissions, lifecycle activities, and inspections, while promoting data integrity and standardization.