PQV Combination Product Analyst IV

About the role

The PQV Combination Product Analyst IV is responsible for high‑volume end‑to‑end product quality complaint handling and adverse event assessment, including Medical Device Reporting (MDR). The role collaborates with multiple internal and external stakeholders to drive process improvements and ensure regulatory compliance.

Key responsibilities

• Perform intake, triage, review, and MDR assessment for product quality complaints.
• Lead investigations, trend analysis, defect coding, risk criticality assessment, and ensure timely closure.
• Provide guidance on complaint handling and MDR processes to junior analysts and other PQV functions.
• Coordinate root‑cause analysis, corrective actions, and CAPA documentation.
• Support internal and external audits, inspections, and regulatory interactions.
• Develop and maintain SOPs, work instructions, and training materials for complaint management.

Required profile

• 5+ years of experience in Quality Assurance/Control within pharmaceutical, medical device, or similarly regulated industry.
• Strong knowledge of regulatory requirements (21 CFR parts 4, 820, 803, 806, 210, 211, 314; ICH Q10; GDP; GMP; GVP; ISO 13485; ISO 14971; MEDEV; CMDR; Medical Device Directive 93/42/EEC).
• Proven ability to lead projects, influence stakeholders, and drive change initiatives.
• Bachelor’s or Master’s degree in a technical, scientific, or engineering discipline.

Required skills

• Regulatory standards: 21 CFR parts 4, 820, 803, 806, 210, 211, 314; ICH Q10; GDP; GMP; GVP.
• Quality standards: ISO 13485:2003, ISO 14971:2007/2012, MEDEV 2.12, CMDR, Medical Device Directive 93/42/EEC.
• Process mapping, root‑cause analysis, risk assessment tools, statistical data analysis.