HCLTech WalkIn Medical/Life science in Chennai on 30th May
Core
Managing global complaint trends and post-market surveillance for medical devices to ensure regulatory compliance and product safety.
Role type
Senior Regulatory Quality Engineer (Medical Devices)
Builds
Audit-ready documentation and risk-based conclusions for global complaint trending signal reports.
Domain
Medical Devices / Life Sciences / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA 21 CFR Part 820 compliance, ISO 13485 standards, post-market surveillance, root cause analysis (RCA), statistical trending methodologies, technical scientific writing, cross-functional collaboration
Preferred skills
Experience in IPC reviews, mapping field feedback to manufacturing operations
Technologies
Data analysis tools
Responsibilities
Determine compliance dispositions for trend signals and document technical rationales for CAPA escalation; Author comprehensive Global Complaint Trending Signal Reports; Conduct RCA on confirmed product trends with Quality Engineering, R&D, and Medical Affairs; Maintain audit-ready documentation aligned with global regulatory standards
Seniority
Senior, hands-on IC