Senior MDRIM & Document Management Specialist

Johnson & Johnson MedTech; Warszawa; On-site; PLN 186,000 - 299,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson MedTech in Warsaw, Poland, seeks a Sr. Specialist, MDRIM & Document Management to support regulatory information governance across international markets.

You will ensure data integrity, manage MDRIM and controlled documents, collaborate with Regulatory Affairs, Quality, R&D, and Manufacturing, and contribute to submissions, audits, and continuous improvement in a regulated medical device environment.

Qualifications

• 4–6 years of relevant experience in regulatory affairs, quality systems, document management, MDRIM, or related functions.
• Experience working with controlled documentation and document management systems.
• Knowledge of quality management systems and regulatory documentation requirements.
• Strong attention to detail with demonstrated ability to manage complex documentation and data accurately.
• Experience collaborating across functions in a matrixed environment.
• Proficiency with Microsoft Office applications and document management tools.

Responsibilities

• Manage and maintain MDRIM and controlled document management activities in accordance with established quality systems, regulatory requirements, and internal procedures.
• Ensure the accuracy, completeness, and integrity of regulatory information, metadata, and controlled documents within applicable systems and repositories.
• Support the 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 ensure documentation and regulatory information requirements are met.
• Provide subject matter expertise on document management processes, data governance standards, workflows, and system requirements.
• Monitor document and data quality metrics, identify discrepancies, and drive timely resolution of documentation and regulatory information issues.
• Support regulatory submission and registration activities by ensuring required documentation and data are maintained and readily accessible.
• Contribute to inspection, audit, and compliance readiness efforts through effective document control and regulatory information management practices.
• Participate in continuous improvement initiatives to enhance MDRIM and document management processes, standardization, efficiency, and compliance.
• Assist with user training, process guidance, and procedural updates related to MDRIM and document management activities.
• Maintain documentation records, reports, and dashboards to support operational reviews and management decision-making.
• Apply DePuy Synthes quality principles and Johnson & Johnson Credo values in all activities.

Skills

MDRIM

Document management

Quality systems

Regulatory affairs

Data governance

Cross-functional collaboration

Microsoft Office

Education

Bachelor's degree

Master's degree

Tools

Document management systems

Job description

Johnson & Johnson MedTech in Warsaw, Poland, seeks a Sr. Specialist, MDRIM & Document Management to support regulatory information governance across international markets.

You will ensure data integrity, manage MDRIM and controlled documents, collaborate with Regulatory Affairs, Quality, R&D, and Manufacturing, and contribute to submissions, audits, and continuous improvement in a regulated medical device environment.