CQ/RA Specialist

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Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Budapest, Hungary, Warsaw, Masovian, Poland

Job Description:

DePuy Synthes is recruiting for a(n) CQ/RA Specialist, located in Warsaw, Poland.

Job Overview

The CQ/RA Specialist plays a key role within QARA International, responsible for regulatory and commercial quality compliance of medical devices distributed on CEE Central Region market .

This role ensures RA and CQ initiatives are delivered on time, in alignment with DePuy Synthes quality systems and regulatory expectations.

The position partners closely with Supply Chain, and Commercial teams and directly supports compliance, patient safety, and operational excellence in a complex, global distributor environment.

Key Responsibilities


* Lead and manage QARA projects, ensuring alignment with global and regional quality and regulatory strategies.



* Ensure regulatory clearance of medical devices being in product portfolio of MDs within timelines.

Coordination and preparation of product notifications.

Managing product submissions.



* Responsible for updates and approvals in systems linked to job duties and maintaining RA databases



* Review of copy review materials for CEE Central region.



* Provide regulatory support to relevant teams and partners - Tender, Health Economics & Reimbursement, Business, Distributors and Franchises and deliver RA trainings to local clusters.



* Provide communication and updates to management regarding regulatory affairs.



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* Coordinate cross‑functional stakeholders, including, Supply Chain, Procurement, and Commercial teams, to drive project execution.



* Support implementation and maintenance of distributor quality requirements, including onboarding, oversight, remediation, and continuous improvement activities.



* Prepare and deliver clear project updates, dashboards, and communications to QARA and business leadership.



* Ensure distributor‑related project activities comply with internal quality systems, regulatory requirements, and governance standards.



* Prom...