Job Description
Designation – Technical Documentation Specialist (Senior Executive)
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nExperience:
n3-8 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.
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nRequired Skills & Experience
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Technical Writing & Documentation Managementn
Design History File (DHF) Preparationn
Device Master Record (DMR) Managementn
Technical Documentation & Design Dossiersn
Risk Management Documentation (ISO 14971)n
Regulatory Documentation & Product Registration Supportn
Design Control Requirementsn
Change Control (ECR/ECO)n
CAPA Systems Knowledgen
Traceability Matrix Developmentn
Quality Management System Documentationn
Solid Communication & Cross-functional Collaborationn
MS Office & Document Control Systems Proficiencyn

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nKey Competencies
nTechnical:
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Technical Writing and Documentationn




Design Controls Documentationn
Risk-Based Thinkingn
Regulatory Documentationn
Traceability Managementn
Root Cause Analysisn
Quality Systems Compliancen

nBehavioural:
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Robust Attention to Detailn
Excellent Communication Skillsn
Analytical Thinkingn
Problem Solvingn
Team Collaborationn
Planning and Organizationn
Accountabilityn
Continuous Improvement Mindsetn

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nQualifications and Experience:
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Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline.n
Master’s degree in quality assurance, Regulatory Affairs, or related field preferred.n
3 to 5 years of experience in regulated medical device environments.n
Experience supporting product development from concept through commercialization.n
Experience with ISO 13485, ISO 14971, EU MDR 2017/745, Design Controls, Technical Documentation, CAPA Systems, and Change Control processe

📌 Technical Documentation Specialist Devsaki (India)
🏢 Zydus Medtech
📍 India