Position Details:

Position: Assistant Manager QA/RA

Experience: 35 years in the IVD Industry

Qualification: M.Pharm, M.Sc. (Chemistry, Biochemistry, Microbiology, Biomedical Sciences), M.Tech, or equivalent postgraduate degree

Job Summary

We at Trivitron Healthcare are seeking an experienced Assistant Manager – QA/RA to support Quality Assurance and Regulatory Affairs functions for our ISO 13485-certified In Vitro Diagnostic (IVD) product portfolio. The incumbent will play a critical role in ensuring compliance with EU IVDR (Regulation (EU) 2017/746) /MDSAP/ Global Registration /ISO 13485 :2016 Documentation compliance/ and other applicable international regulations, while supporting complaint handling, post-market surveillance, quality system compliance, technical documentation management, and global product registrations.

The role requires hands-on experience in IVDR implementation, technical file preparation, performance evaluation documentation, regulatory submissions,



and coordination with Notified Bodies to ensure timely regulatory approvals and uninterrupted market access.

Key Responsibilities

Quality Assurance
- Manage end-to-end complaint handling activities, including investigation, root cause analysis, CAPA implementation, and closure.
- Maintain complaint records and ensure compliance with ISO 13485 and EU IVDR post-market requirements.
- Support and execute Post-Market Surveillance (PMS) activities, including PMS Plans, PMS Reports, trend analysis, vigilance reporting, and Post-Market Performance Follow-up (PMPF) activities.
- Participate in risk management activities in accordance with ISO 14971 and ensure risk files remain updated throughout the product lifecycle.
- Conduct internal audits and support supplier audits to verify compliance with Quality Management System requirements.
- Support management of CAPA, deviations, change controls, and continuous improvement initiatives.
- Ensure Quality Management System documentation is maintained in

📌 Quality Assurance (Navi Mumbai)
🏢 Trivitron Healthcare
📍 Navi Mumbai