Full-time

Regulatory Executive

Posted by Meril • Vapi, Gujarat, India

📍 Vapi, Gujarat 🕒 March 03, 2026

About the Role

Job Title:

Executive – Regulatory & Technical Documentation

Department:

Quality Assurance & Regulatory Affairs (QA / RA) – Women’s Health & Fertility

Location:

Vapi, Gujarat

Reports To:

Manager / Senior Manager – QA / RA


Job Purpose:

To prepare, review, and control technical, quality, and validation documentation for Women’s Health & Fertility / IVF medical devices, supporting R&D and Production activities, ensuring compliance with ISO 13485, IEC 60601-1, and applicable regulatory requirements, and enabling timely DCGI submissions, Test License approvals, and product commercialization.


Key Responsibilities: –

1. QMS & Technical Documentation

• Prepare, review, and maintain QMS documents, design documentation, DOE records, protocols, and ...

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