Job Title:

Executive / Sr. Executive – Regulatory Documentation (Neonatal Medical Devices)

Department:

R&D / Quality Assurance – Neonatal Division

Location:

Vapi, Gujarat

Reports To:

Manager / Senior Manager – R&D / QA – Neonatal Segment

Job Purpose:

To prepare, maintain, and control structured technical, regulatory, and quality documentation for neonatal electro-mechanical medical devices including incubators, radiant warmers, phototherapy units, Bubble CPAP systems, infant resuscitators, and physiological monitors.

The role ensures compliance with CDSCO Medical Device Rules (MDR 2017), ISO 13485, ISO 14971, IEC 60601 series, and other applicable standards, supporting regulatory approvals, audit readiness, and complete lifecycle traceability from design and development to commercialization.

Key Responsibilities:

1. Regulatory & Technical File Preparation

• Prepare and maintain Technical Files in accordance with CDSCO Medical Device Rules (MDR 2017).

• Compile and manage Device Master Files (DMF), Plant Master Files (PMF), and regulatory submission dossiers.

• Ensure documentation alignment with ISO 13485 Quality Management System requirements.

• Support license applications, renewals, and regulatory submissions.

• Maintain document readiness for CDSCO inspections and external audits.

2. Design History File (DHF) & Design Control

• Develop and maintain complete Design History Files (DHF) including design inputs, outputs, review records, verification, validation, and design transfer documents.

• Establish and maintain traceability matrices linking design inputs to risk controls and V&V evidence.

• Support Engineering Change Requests (ECR) and Engineering Change Orders (ECO).

• Ensure proper documentation of design reviews and approval records.

3. Risk Management Documentation

• Prepare and update Risk Management Files in compliance with ISO 14971.

• Conduct and document hazard analysis, DFMEA/PFMEA, and risk-benefit analysis.

• Ensure mitigation measures are traceable to validation reports and labelling controls.

• Update risk documentation based on field feedback, complaints, and CAPA.

4. System-Level Documentation – Neonatal Electro-Mechanical Devices

• Document thermal regulation systems including servo control logic, heater performance validation, and temperature uniformity testing (Incubators & Warmers).

• Prepare airflow and respiratory system documentation for Bubble CPAP including flow accuracy, pressure stability, and humidity control.

• Document alarm systems including safety classification, alarm logic, and performance validation.

• Maintain sensor integration documentation (temperature probes, SpO₂, pressure sensors, physiological parameters).

• Compile electrical safety and EMC compliance documentation as per IEC 60601 standards.

• Maintain mechanical integration documentation including structural safety, enclosure design, and material compliance.

• Coordinate software documentation (if applicable) aligned with IEC 62304 lifecycle requirements.

5. Verification & Validation (V&V) Documentation

• Prepare V&V protocols and reports covering performance, safety, electrical safety, EMC, environmental, and stress testing.

• Support usability validation and human factor documentation (IEC 62366).

• Coordinate with internal labs and external test agencies for report compilation.

• Ensure validation evidence supports regulatory submissions and audit compliance.

6. Product Specifications & Labelling Control

• Prepare and maintain product specifications, technical datasheets, and revision-controlled engineering documentation.

• Develop and review Instructions for Use (IFU), labelling, packaging details, and safety markings.

• Ensure labelling compliance with CDSCO and applicable international regulatory requirements.

• Maintain BOM documentation and document change control records.

7. Audit & Lifecycle Compliance

• Support ISO 13485 surveillance audits and regulatory inspections.

• Maintain documentation traceability throughout product lifecycle.

• Update technical files based on CAPA, field complaints, design changes, and regulatory updates.

• Ensure structured document control within QMS/ERP/PLM systems.

Qualifications and Experience:

• B.E. / B. Tech in Mechanical, Electronics, or Biomedical Engineering.

• 2–3 years of experience in medical device technical documentation.

• Experience in neonatal, critical care, or life-support medical devices preferred.

• Strong knowledge of ISO 13485, ISO 14971, IEC 60601 series, and CDSCO Medical Device Rules.

• Experience in preparing DHF, DMF, Technical Files, and risk management documentation.

Skills and Competencies:

• Strong technical writing and documentation structuring skills.

• Deep understanding of electro-mechanical medical device integration.

• Knowledge of neonatal device clinical applications and safety requirements.

• High attention to detail and regulatory interpretation capability.

• Strong cross-functional coordination skills (R&D, QA, Regulatory, Production).

• Proficiency in MS Office, document control systems, ERP/PLM tools.

Key Performance Indicators (KPIs):

• Timely completion of Technical Files and DHF documentation

• Zero major documentation non-conformities during audits

• Regulatory submission success rate

• Traceability accuracy across design and risk documentation

• Reduction in audit observations related to documentation

• Contribution to faster product approvals and commercialization readiness

apply or refer to [HIDDEN TEXT]

Documentation Executive