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Salary: PLN 185,500 - 299,000 / annual
DePuy Synthes (Johnson & Johnson's medical device division, undergoing planned separation) is seeking a Senior Specialist for Medical Device Regulatory Information Management (MDRIM) and Document Management in Warsaw, Poland.
In this role, you will serve as a subject matter expert responsible for managing, maintaining, and governing regulatory information and controlled documentation within the QARA International function. You will ensure regulatory data integrity, document compliance, and adherence to global quality and regulatory requirements across international markets.
Key responsibilities include:
- Manage and maintain MDRIM and controlled document management activities in accordance with quality systems, regulatory requirements, and internal procedures
- Ensure accuracy, completeness, and integrity of regulatory information, metadata, and controlled documents within applicable systems and repositories
- Support 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 cross-functional stakeholders to meet documentation and regulatory information requirements
- 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 issues
- Support regulatory submissions and registration activities by ensuring required documentation is maintained and accessible
- Contribute to inspection, audit, and compliance readiness efforts through effective document control and regulatory information management
- 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
- 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
You will work in a matrixed environment, partnering closely with multiple functional teams to support regulatory submissions, product lifecycle activities, inspections, and continuous process improvements.
Qualifications:
- Bachelor's degree required in Life Sciences, Engineering, Quality, Regulatory Affairs, Information Management, or related discipline (Master's degree preferred)
- 4–6 years of relevant experience in regulatory affairs, quality systems, document management, MDRIM, or related functions within a regulated industry
- 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
- Fluency in English required; Polish preferred; additional languages are an advantage
- Limited travel required (up to 10% international)
Preferred experience:
- Supporting MDRIM processes and systems
- Familiarity with EU MDR, IVDR, and applicable global medical device regulatory requirements
- Experience supporting regulatory submissions, registrations, or product lifecycle management activities
- Experience working in a global medical device, pharmaceutical, or healthcare organization
- Knowledge of data governance, document control, and regulatory information management best practices
