Technical Documentation Specialist

Zydus MedTech; Surat; On-site; INR 2,500,000 - 3,800,000; Full time

Job summary

Zydus MedTech in Surat, India, seeks an R&D Technical Documentation Specialist (Associate Manager) with 9-11 years in medical devices for DHF/DMR, regulatory documentation and Design Controls. Strong cross-functional collaboration and regulatory liaison skills are essential.

The role involves ensuring regulatory readiness, maintaining QMS documentation, and supporting product development from concept through commercialization in a fast-paced R&D environment.

Qualifications

• 9 to 11 years of experience in regulated medical device environments.
• Experience with ISO 13485, ISO 14971, EU MDR 2017/745, and CAPA systems.
• Experience with Change Control processes.
• Experience supporting international regulatory submissions preferred.

Skills

Technical Writing

DHF Preparation

DMR Management

Regulatory Documentation

Design Controls

Change Control

Traceability

QMS Documentation

Cross-functional Collaboration

Education

Bachelor's degree

Master's degree (QA/Regulatory)

Job description

Designation – R&D Technical Documentation Specialist (Associate Manager)

Experience:

9-11 years in Medical Device Industry with direct experience in Design Controls, Technical Documentation, DHF Management, Regulatory Documentation, or Quality Systems. Experience in cardiovascular medical devices and international regulatory submissions will be preferred.

Required Skills & Experience

• Technical Writing & Documentation Management
• Design History File (DHF) Preparation
• Device Master Record (DMR) Management
• Regulatory Documentation & Product Registration Support
• Design Control Requirements
• Change Control (ECR/ECO)
• Traceability Matrix Development
• Quality Management System Documentation
• Strong Communication & Cross-functional Collaboration

Technical:

• Technical Writing and Documentation
• Design Controls Documentation
• Risk-Based Thinking
• Regulatory Documentation
• Traceability Management
• Quality Systems Compliance

Qualifications and Experience:

• Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline.
• Master’s degree in quality assurance, Regulatory Affairs, or related field preferred.
• 9 to 11 years of experience in regulated medical device environments.
• Experience supporting product development from concept through commercialization.
• Experience with ISO 13485, ISO 14971, EU MDR 2017/745, Design Controls, Technical Documentation, CAPA Systems, and Change Control processes.
• Experience supporting international regulatory submissions preferred.