LS -System Engineer| 9 years T0 12 years | Bangalore

The ideal candidate will possess a robust understanding of medical terminology, medical device regulations, risk communication, human factors/usability principles, and regulatory requirements across global markets. This role will work closely with Regulatory Affairs, Clinical Affairs, Quality, R&D;, Product Management, and Technical Publications teams to ensure documentation meets regulatory, quality, and user requirements.
Key Responsibilities
Labelling & IFU Development
Develop, review, and maintain:
Instructions for Use (IFU)
User Manuals
Quick Reference Guides
Product Labeling
Package Inserts
Training Materials
eIFU content
Translate complex clinical and technical information into accurate, user-friendly documentation.
Ensure consistency of labelling, warnings, precautions, contraindications, indications for use, and safety information.
Support localization and translation reviews for global product releases.
Regulatory Documentation
Ensure all documentation complies with applicable regulatory requirements and standards.




Support regulatory submissions and product registrations by providing required documentation.
Review documentation against global regulatory expectations and labelling regulations.
Maintain documentation traceability and version control.
Cross-Functional Collaboration
Partner with:
Regulatory Affairs
Clinical Affairs
Quality Assurance
Risk Management
Human Factors Engineering
Product Development Teams
Participate in design reviews and product development activities.
Gather and validate information from Subject Matter Experts (SMEs).
Risk & Safety Communication
Ensure labelling accurately communicates risks, warnings, precautions, contraindications, and adverse events.
Collaborate with risk management teams to align documentation with risk assessments and hazard analyses.
Support usability and human factors evaluations for customer-facing documentation.
Quality & Compliance
Ensure documentation

📌 Life Science- System Engineer (Bengaluru)
🏢 Capgemini Engineering
📍 Bengaluru