Job Title: Documentation Executive.
Department: Research & Development (R&D;) – Women Genesis.
Location: Vapi, Gujarat.
Reports To: Manager / Senior Manager.
Job Purpose:
To prepare, review, control, and maintain design, technical, quality, and regulatory documentation throughout the product development lifecycle for Women's Healthcare medical devices. The role ensures compliance with applicable regulatory standards, Quality Management System (QMS) requirements, and company procedures while supporting R&D;, product development, validation, technology transfer, and regulatory submissions.
Key Responsibilities:
1. Design & Technical Documentation
Prepare, review, and maintain Design History Files (DHF), Design Inputs, Design Outputs, Design Verification & Validation documents, Design Review records, Design Change documentation, Design of Experiments (DOE), protocols, reports, and technical specifications.
Prepare and maintain Device Master Records (DMR), Batch Manufacturing Records (BMR), Standard Operating Procedures (SOPs), Work Instructions (WIs), forms, engineering documents,
and project documentation.
Develop and maintain Technical Files supporting product development and commercialization.
Ensure documentation is complete, accurate, traceable, and maintained throughout the product lifecycle.
2. Regulatory Documentation
Prepare documentation required for Test License, CDSCO, CE MDR, and Rest of World (ROW) regulatory submissions.
Prepare and maintain product artwork, labels, Instructions for Use (IFUs), packaging inserts, and packaging documentation.
Coordinate timely submission of project documents to the Regulatory Affairs department.
Ensure all documentation complies with ISO 13485, CE MDR, CDSCO, and company Quality Management System requirements.
3. Document Control & Quality Management
Maintain document revision history, version control, approvals, distribution, traceability, and archival in accordance with document control procedures.
Monitor document statu
📌 Documentation Executive (Vapi)
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📍 Vapi