Experience

HCLTech – Engineering and R&D Services

• IT Services and IT Consulting
• 500 - 600 Employee

• Member Technical staff - Regulatory Engineer

  • Jan 2021 - Present

  I conducted a comprehensive R&D gap analysis for all classifications of medical devices, focusing on the General Safety and Performance Requirements (GSPR) and Annex II of the EU Medical Device Regulation (MDR). • I prepared and developed various essential documents for medical devices, specifically vascular surgical products. These documents included the Summary of Technical Documentation (STED), General Safety and Performance Requirement Checklist (GSPRC), Design History File (DHF), Design Verification and Validation report, Risk Management Files (RMF), and Traceability Matrix. These comprehensive documents were carefully compiled and organized to meet the requirements for submission to Notified Bodies such as TUV and BSI. • I possess extensive practical experience and a broad understanding of key regulations and standards such as EU MDR 2017/745, UK MDR, 21 CFR Part 820, ISO 13485, ISO 14971, ISO 15223, ISO 20417, ISO 10993-1, ISO 22442 and ASTM D4169. • I am actively engaged in the process of updating and reviewing labeling and Instructions for Use (IFU). • I have experience in preparing submissions for the initial registration, license renewal, and change notifications of Class I, II, and III medical devices. • I am actively involved in preparing regulatory dossiers for China and developing product technical requirements (PTR). • I possess a strong comprehension of risk management processes for medical devices, including DFMEA, UMFMEA, PFMEA, and RACT. • I have a foundational understanding of geography-specific regulatory requirements for medical devices in various regions, including APAC, LATAM, EMEA, Canada, China, and Russia. • I have hands-on experience in change control management, particularly in handling material/design changes, legacy conversions, and supplier changes. • I possess extensive knowledge and practical experience in adhering to Good Documentation Practices (GDP). Show less