Regulatory Affairs Document Specialist

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 technical r...