Technical Documentation Specialist

Zydus MedTech; Surat; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Zydus MedTech in Surat, Gujarat, India seeks a Technical Documentation Specialist (Senior Executive) with 3–5 years in regulated medical device environments to drive Design Controls, DHF and regulatory documentation from concept through commercialization.

The role emphasizes rigorous documentation, CAPA systems, change control, risk management, and cross-functional collaboration with engineering and quality teams. Bachelor’s degree required; Master’s preferred.

Qualifications

• Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline.
• Master’s degree in quality assurance, Regulatory affairs, or related field preferred.
• 3–5 years of experience in regulated medical device environments.
• 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.

Skills

Technical Writing

DHF Preparation

DMR Management

Regulatory Docs

Design Controls

Change Control

CAPA Systems

Traceability

Quality Systems

Cross-functional Communication

Education

Bachelor's in Engineering/Life Sciences/Pharmacy

Master’s in QA/Regulatory Affairs

Tools

MS Office

Document Control Systems

Job description

Designation – Technical Documentation Specialist (Senior Executive)

Experience:

3-8 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
• Technical Documentation & Design Dossiers
• Risk Management Documentation (ISO 14971)
• Regulatory Documentation & Product Registration Support
• Design Control Requirements
• Change Control (ECR/ECO)
• CAPA Systems Knowledge
• Traceability Matrix Development
• Quality Management System Documentation
• Strong Communication & Cross-functional Collaboration
• MS Office & Document Control Systems Proficiency

Key Competencies

Technical:

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

Behavioural:

• Strong Attention to Detail
• Excellent Communication Skills
• Analytical Thinking
• Problem Solving
• Team Collaboration
• Planning and Organization
• Accountability
• Continuous Improvement Mindset

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.
• 3 to 5 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.