Technical Documentation Specialist

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.