Documentation Executive

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. Regulato...