Job Overview
DePuy Synthes is recruiting for a Sr. Specialist, MDRIM & Document Mgmt., located in Warsaw, Poland.
The Sr. Specialist, MDRIM & Document Management is responsible for supporting the management, maintenance, and governance of regulatory information and controlled documentation within QARA International. This role serves as a subject matter expert for MDRIM and document management processes, ensuring regulatory data integrity, document compliance, and adherence to global quality and regulatory requirements.
The Sr. Specialist partners closely with Regulatory Affairs, Quality, R&D, Manufacturing, and other cross-functional stakeholders to support regulatory submissions, product lifecycle activities, inspections, and continuous process improvements. This role contributes to operational excellence by ensuring accurate, compliant, and efficient management of regulatory information and documentation across international markets.
Key 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.
Qualifications
Education
•Bachelor's degree required in Life Sciences, Engineering, Quality, Regulatory Affairs, Information Management, or a related discipline.
•Master's degree preferred.
Experience and Skills — Required
•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.
Experience and Skills — Preferred
•Experience supporting MDRIM (Medical Device Regulatory Information Management) 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.
Other
•Language: Fluency in English required; Polish preferred; additional languages are an advantage.
•Travel: Limited; up to 10% international travel may be required.
Preferred Skills
Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking
Pay
The anticipated base pay range for this position is: zł191,000.00 - zł308,200.00
Benefits
In addition to base pay, benefits include an annual bonus with set target (% of pay) depending on pay grade / location, or sales commissions. Also offered: vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health. Service anniversary and recognition awards are provided, and employees (and in some locations eligible dependents) can participate in several insurance plans.
Note on Business Separation
Johnson & Johnson announced plans to separate its Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process is anticipated to be completed within 18 to 24 months, subject to legal requirements, regulatory approvals and other customary conditions. Should the candidate accept this position, following conclusion of the transaction they would be an employee of DePuy Synthes and employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans.
