3i Concept Medical Device Solutions

Key Responsibilities: 1. Design History File (DHF) Preparation and Technical File Compilation for Notified Body Submission · Compile and maintain DHF documentation as per ISO 13485 and FDA 21 CFR Part 820 requirements. · Support preparation of EU MDR (2017/745) technical files, including General Safety and Performance Requirements (GSPR) checklist. · Ensure alignment with ISO 11608, ISO 11040, and other applicable standards for drug–device combination products. · Support creation of Threshold Analysis Reports and justification in line with FDA guidance. 4. Risk Management · Creation and maintenance of Risk Management Files (RMF) as per ISO 14971:2019. · Identify potential hazards, evaluate risk control measures, and prepare FMEA tables. 5. Device Development & Combination Product Documentation · Support preparation of design documentation for drug–device combination products such as pre-filled syringes, pen injectors, autoinjectors, and IV systems. · Collaborate with cross-functional teams to capture development data, component specifications, and testing results. Job Types: Full-time, Fresher Pay: ₹10,000.00 - ₹13,000.00 per month Work Location: In person