Documentation Executive

Overview

The Documentation Executive role in the Research & Development department of Women's Healthcare medical devices at Meril, based in Vapi, Gujarat, involves preparing and maintaining critical documentation throughout the product development life cycle. This position supports compliance with regulatory standards, Quality Management System protocols, and internal procedures essential for R&D, product development, validation, technology transfer, and regulatory approval processes.

Primary Responsibilities

• Compose, review, and update Design History Files (DHF), Design Inputs/Outputs, Design Verification & Validation documents, Design Reviews, Design Change records, Design of Experiments (DOE) documentation, technical protocols, and reports.
• Create and sustain Device Master Records (DMR), Batch Manufacturing Records (BMR), Standard Operating Procedures (SOPs), Work Instructions (WIs), forms, engineering files, and project documentation.
• Develop comprehensive Technical Files to assist with product development and commercialization.
• Prepare required regulatory submission materials including Test License applications, CDSCO filings, CE MDR compliance documents, and submissions for other international markets.
• Handle product artwork, labeling, Instructions for Use (IFUs), packaging inserts, and packaging documentation in compliance with regulatory standards.
• Maintain document control elements such as revision history, approvals, distribution, traceability, and archival as per company procedures.
• Monitor documentation progress to ensure deadlines are met and support audit preparedness through accurate records.
• Collaborate with cross-functional teams including R&D, Quality Assurance, Regulatory Affairs, Production, Engineering, and Clinical Affairs to complete documentation requirements.
• Assist with internal, external, customer, and regulatory audits by supplying precise and compliant documents.
• Support quality improvement initiatives including Corrective and Preventive Actions (CAPA), change control, and continuous documentation process enhancement.

Qualifications & Experience

• Bachelor's degree in Biomedical Engineering, Biotechnology, Pharmacy, Life Sciences, Mechanical Engineering, or related field.
• Two to three years experience in documentation, quality assurance, regulatory affairs, or technical documentation within the medical device, pharmaceutical, or healthcare industries.
• Experience with medical device regulatory documentation and product development preferred.

Skills & Competencies

• Comprehensive knowledge of ISO 13485, CE MDR, CDSCO, and Quality Management Systems for medical devices.
• Expertise in preparing technical files such as DHF, DMR, SOPs, WIs, BMRs, DOE documents, validation protocols, and regulatory submissions.
• Familiarity with Design Control, Risk Management, Change Control methodologies, and document control standards.
• Proficient in Microsoft Office and Electronic Document Management Systems (eDMS).
• Excellent written communication, organizational capability, and meticulous attention to detail.
• Strong analytical skills and ability to coordinate across multiple teams.
• Ability to manage various projects and meet tight timelines.
• Self-driven with a proactive mindset towards maintaining compliance and improving processes.

Performance Indicators

• Meeting deadlines for document preparation and submission.
• Zero critical findings during internal and external quality audits.
• Regulatory compliance consistent with applicable standards and company QMS.
• Accurate and thorough revision control and traceability of documentation.
• Effective support of product development, validation, technology transfer, and regulatory inspections.
• Ongoing improvements in documentation efficiency and quality.
• Strong interdepartmental communication leading to timely project completions.