Senior MDRIM & Document Management Specialist

Johnson & Johnson Co.; Warszawa; In loco; PLN 191.000 - 308.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Vacation days

Parental leave

Descrizione del lavoro

Johnson & Johnson in Warsaw, Poland, is seeking a Sr. Specialist, MDRIM & Document Management, to govern regulatory information and controlled documents across international markets.

You will work with Regulatory Affairs, Quality, R&D and Manufacturing to ensure compliant documentation throughout the product lifecycle. The role requires 4–6 years in regulatory affairs or related fields, strong attention to detail, and experience with MDRIM.

Competenze

• Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs, Information Management, or related discipline.
• 4–6 years of regulatory affairs, quality systems, document management, MDRIM, or related functions.
• Experience with controlled documentation and document management systems.
• Fluent in English; Polish preferred; other languages are a plus.

Mansioni

• Manage MDRIM and controlled document management activities per quality systems and regulatory requirements.
• Ensure accuracy and integrity of regulatory information and documents in systems.
• Support creation, review, processing, and maintenance of regulatory documentation across product lifecycles.
• Collaborate with Regulatory Affairs, Quality, R&D, Manufacturing and other stakeholders to meet documentation needs.
• Provide SME on document management processes, data governance, workflows and system requirements.
• Monitor data quality metrics and drive resolution of issues.
• Support regulatory submissions and registrations; maintain accessibility of documents.
• Contribute to inspections, audits and compliance readiness through document control.

Conoscenze

Regulatory affairs

Document management

Quality systems

MDRIM

MS Office

Formazione

Bachelor's degree in Life Sciences/Engineering/Quality/Regulatory Affairs

Master's degree preferred

Strumenti

Microsoft Office

Descrizione del lavoro

Johnson & Johnson in Warsaw, Poland, is seeking a Sr. Specialist, MDRIM & Document Management, to govern regulatory information and controlled documents across international markets.

You will work with Regulatory Affairs, Quality, R&D and Manufacturing to ensure compliant documentation throughout the product lifecycle. The role requires 4–6 years in regulatory affairs or related fields, strong attention to detail, and experience with MDRIM.