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 status and ensure completion within established project timelines.
Maintain effective document control systems to support regulatory compliance and audit readiness.
Drive continuous improvement initiatives to enhance documentation quality and efficiency.

4. Cross-Functional Coordination

Collaborate with R&D, Quality Assurance, Regulatory Affairs, Production, Engineering, Clinical Affairs, and Manufacturing teams for documentation preparation and review.
Support product development, process validation, product transfer, engineering changes, and manufacturing documentation activities.
Follow up with cross-functional teams to ensure timely completion and approval of project documents.

5. Quality, Compliance & Audit Support

Support internal audits, external audits, customer audits, and regulatory inspections by providing accurate and timely documentation.
Ensure documentation confidentiality, integrity, completeness, and regulatory compliance.
Support implementation of Quality Assurance and Regulatory Affairs requirements across assigned projects.
Assist in CAPA implementation, change control documentation, and continuous quality improvement initiatives.

Qualifications and Experience:

Bachelor's degree in Biomedical Engineering, Biotechnology, Pharmacy, Life Sciences, Mechanical Engineering, or a related discipline.
2–3 years of experience in documentation, Quality Assurance, Regulatory Affairs, or technical documentation within the medical device, pharmaceutical, or healthcare industry.
Experience in regulated medical device documentation and product development will be preferred.

Skills and Competencies:

Strong knowledge of ISO 13485, CE MDR, CDSCO, and medical device Quality Management Systems.
Experience in preparing DHF, DMR, Technical Files, SOPs, WIs, BMRs, DOE documents, validation protocols, reports, and regulatory submission documentation.
Knowledge of Design Control, Risk Management, Change Control, and document control processes.
Proficiency in Microsoft Office applications and Electronic Document Management Systems (eDMS).
Excellent technical writing, documentation, and organizational skills.
Strong analytical abilities with exceptional attention to detail.
Effective communication and cross-functional coordination skills.
Ability to manage multiple projects and deliver documentation within strict timelines.
Self-motivated with a proactive approach to continuous improvement and regulatory compliance.

Key Performance Indicators (KPIs):

Timely completion and submission of project documentation.
Zero critical documentation non-conformities during internal and external audits.
Compliance with ISO 13485, CE MDR, CDSCO, and company QMS requirements.
Timely preparation of Technical Files, DHFs, regulatory submission documents, and product documentation.
Accuracy and completeness of document revisions, traceability, and document control records.
On-time support for product development, validation, and technology transfer projects.
Successful support during regulatory inspections and customer audits.
Continuous improvement in documentation processes and reduction in documentation turnaround time.
Effective cross-functional coordination and on-time closure of documentation activities.
Compliance with project milestones and documentation deliverables.