Design Documentation & Validation - Senior Executive

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 documentation throughout the medical device product development lifecycle, ensuring compliance with global regulatory requirements and quality management systems. The role involves Design History File (DHF) management, Design Verification & Validation (V&V), Risk Management, Technical Documentation, and regulatory submission support in accordance with ISO 13485, ISO 14971, MDR, FDA, CDSCO, and other applicable medical device standards.

Key Responsibilities:

1. Design Documentation & Design Control

• Prepare, review, and maintain Design History File (DHF), Device Master Record (DMR), Technical Documentation, and Design Contr...