CQ/RA Specialist (Medical Devices)

Location: Warsaw, Masovian, Poland; hybrid work arrangement. Limited travel may be required.

Base pay: zł121,000.00–zł194,350.00 annually.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions, with this role supporting DePuy Synthes and its medical device portfolio.

What you will do

• Lead QARA projects in alignment with global and regional quality and regulatory strategies.
• Coordinate product notifications, regulatory submissions, clearances, system approvals, and regulatory database maintenance.
• Review copy materials and provide regulatory support to commercial, tender, health economics, reimbursement, distributor, and franchise stakeholders.
• Coordinate Supply Chain, Procurement, Commercial, and other cross-functional partners to execute projects.
• Support distributor quality requirements, including onboarding, oversight, remediation, and continuous improvement.
• Prepare project updates, dashboards, communications, and regulatory training for leadership and local clusters.

Requirements

• Bachelor’s degree in Quality, Regulatory Affairs, Life Sciences, Engineering, Business, or a related discipline.
• 3–5 years of relevant experience in project management, quality, regulatory affairs, or distributor-related work in a regulated environment.
• Experience managing cross-functional, multi-stakeholder projects and multiple priorities in a matrix environment.
• Working knowledge of quality systems, compliance processes, and regulatory requirements.
• Clear communication skills with diverse audiences, including senior leadership.
• Fluency in English is required.

Nice to have

• Experience with distributor management or third-party oversight in medical devices, pharmaceuticals, or healthcare.
• Familiarity with international distributor models and global quality and regulatory expectations.
• Experience with process improvement, remediation, or change management.
• Project management certification or knowledge of PMP, PRINCE2, or Agile methodologies.
• Additional languages and strong planning, organizational, and risk-management skills.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, collaboration, compliance, and continuous improvement.
• Annual bonus with a target based on pay grade and location, subject to employee and company performance.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Insurance plans, service anniversary awards, and recognition programs may be available according to plan terms and location.

Hiring process

• The interview process is designed to accommodate applicants’ accessibility needs.