Job Title: Design Documentation & Validation - Senior Executive. Department: Endoscopy and Women Healthcare Location: Vapi, Gujarat Reports To: Manager / Senior Manager – Endoscopy and Women Healthcare Job Purpose: To prepare, maintain, and manage design
Key Skills: ISO 13485, ISO 14971, IEC 62304, 21 CFR, Design Controls, Risk Management, Traceability Matrix, Medical Device Regulations Roles & Responsibilities: Support post-production risk review activities as per defined regulatory schedules Coordinate with stakeholders to collect and analyze