Job Title:
Executive / Sr. Executive – Regulatory Documentation (Neonatal Medical Devices)
Department:
R&D; / Quality Assurance – Neonatal Division
Location:
Vapi, Gujarat
Reports To:
Manager / Senior Manager – R&D; / QA – Neonatal Segment

Job Purpose:
To prepare, maintain, and control structured technical, regulatory, and quality documentation for neonatal electro-mechanical medical devices including incubators, radiant warmers, phototherapy units, Bubble CPAP systems, infant resuscitators, and physiological monitors.
The role ensures compliance with CDSCO Medical Device Rules (MDR 2017), ISO 13485, ISO 14971, IEC 60601 series, and other applicable standards, supporting regulatory approvals, audit readiness, and complete lifecycle traceability from design and development to commercialization.

Key Responsibilities:
1.



Regulatory & Technical File Preparation
• Prepare and maintain Technical Files in accordance with CDSCO Medical Device Rules (MDR 2017).
• Compile and manage Device Master Files (DMF), Plant Master Files (PMF), and regulatory submission dossiers.
• Ensure documentation alignment with ISO 13485 Quality Management System requirements.
• Support license applications, renewals, and regulatory submissions.
• Maintain document readiness for CDSCO inspections and external audits.

2. Design History File (DHF) & Design Control
• Develop and maintain complete Design History Files (DHF) including design inputs, outputs, review records, verification, validation, and design

📌 Documentation Executive (India)
🏢 Meril
📍 India