Combination Product Analyst IV – Quality Vigilance

About the role

The PQV Combination Product Analyst IV will manage high‑volume end‑to‑end product quality complaint activities and adverse event reporting, including Medical Device Reporting (MDR) assessments. The role collaborates with cross‑functional partners to drive process improvements, ensure regulatory compliance, and support change management across global sites.

Key responsibilities

• Perform intake, triage, review, and prioritization of complaints and MDR assessments, including field sample recovery and QP notification.
• Provide governance for daily complaint throughput, ensure KPI achievement, and conduct trend analysis and defect coding.
• Lead root‑cause investigations, coordinate corrective actions, and maintain documentation in the QMS.
• Support internal and external audits, act as SME during regulatory inspections, and interact with authorities as needed.
• Develop and deliver training on complaint handling, regulatory reporting, and related processes.

Required profile

• 5+ years of experience in Quality Assurance/Control within pharmaceutical, medical device, or similarly regulated industries.
• Strong knowledge of regulatory requirements such as 21 CFR parts 4, 820, 803, 806, 210, 211, 314, ICH Q10, ISO 13485, ISO 14971, MEDEV, CMDR, and the Medical Device Directive.
• Bachelor’s or Master’s degree in a technical, scientific, or engineering discipline.
• Proven ability to lead projects, influence stakeholders, and drive continuous improvement.

Required skills

• Risk assessment and criticality analysis
• Process mapping and improvement tools
• Root‑cause investigation methodologies
• Statistical and data‑driven decision making
• Regulatory reporting (MDR) and compliance documentation