LS -System Engineer| 9 years T0 12 years | Bangalore
The ideal candidate will possess a strong 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 aligns with Quality Management System (QMS) requirements.
- Support internal and external audits, inspections, and regulatory assessments.
- Participate in change control and design control activities.
- Drive continuous improvement in documentation processes and standards.
Education
- Bachelor's or Master's degree in Life Sciences/Pharmacy/Biomedical Engineering/Biotechnology
Experience
- 5 to8 years of relevant experience in medical devices, pharmaceuticals, or healthcare documentation.
- Proven experience developing and reviewing – IFUs, User Manuals, Product Labelling, Regulatory Documentation
Regulatory Knowledge
- Strong knowledge of FDA Medical Device RegulatiF201ons, EU MDR (Medical Device Regulation), ISO 13485, ISO 14971 Risk Management, IEC 62366 Usability Engineering, Medical Device Labelling Requirements, GSPR Requirements and Design Control Documentation
Technical Competencies
- Strong medical writing and technical communication skills.
- Ability to interpret clinical, scientific, and engineering information.
- Excellent understanding of medical terminology and healthcare workflows.
- Experience reviewing and approving regulated documentation.
- Familiarity with document management and quality systems.
