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, DO...
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