- Solid 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 .
- 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.
Preferred candidate profile :
- 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
📌 Life Science System Engineering Lead (Karnataka)
🏢 Capgemini
📍 Karnataka
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