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
- Strong 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)
🏢 Zydus Medtech
📍 Devsaki