CQ/RA Specialist – Medical Devices

About the role

DePuy Synthes is recruiting a CQ/RA Specialist in Warsaw, Poland, within QARA International. The role covers regulatory and commercial quality compliance of medical devices distributed on the CEE Central Region market, ensuring RA and CQ initiatives meet DePuy Synthes quality systems and regulatory expectations. It works closely with Supply Chain and Commercial teams and supports compliance, patient safety and operational excellence.

Key responsibilities

• Lead and manage QARA projects aligned with global and regional quality and regulatory strategies
• Ensure regulatory clearance of medical devices in the product portfolio within timelines, coordinate product notifications and manage product submissions
• Maintain RA databases and review copy review materials for the CEE Central region
• Provide regulatory support to Tender, Health Economics & Reimbursement, Business, Distributors and Franchises teams, and deliver RA training to local clusters
• Update management on regulatory matters and prepare project updates, dashboards and communications for QARA and business leadership
• Coordinate Supply Chain, Procurement and Commercial teams, and support distributor quality requirements including onboarding, oversight, remediation and continuous improvement

Required profile

• Bachelor's degree in Quality, Regulatory Affairs, Life Sciences, Engineering, Business or a related field; Master's degree preferred
• Typically 3-5 years of experience supporting project management, quality, regulatory or distributor-related activities in a regulated environment
• Experience managing cross-functional, multi-stakeholder projects
• Fluency in English; additional languages are an advantage
• Limited travel may be required

Required skills

• Working knowledge of quality systems, compliance processes or regulatory requirements
• Preferred: experience in distributor management or third-party oversight, familiarity with international distributor models, process improvement, change management, and project management methodologies such as PMP, PRINCE2 or Agile
• Planning, organizational and risk-management skills

What we offer

• Base pay range of zloty 125,000 to 200,100
• Annual bonus and/or sales commissions depending on pay grade and location
• Vacation days, parental leave of at least 12 weeks, bereavement, caregiver and volunteer leave, well-being reimbursement and health programmes
• Service anniversary and recognition awards, and insurance plans for eligible employees and dependents