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 line with ISO 13485 and IVDR requirements.

Regulatory Affairs

- Support and manage regulatory registrations, renewals, and submissions for IVD products in international markets.
- Prepare, review, and maintain Technical Documentation as per Annex II and Annex III requirements of EU IVDR.
- Support preparation and maintenance of:
- Performance Evaluation Reports (PER)
- Scientific Validity Reports (SVR)
- Analytical Performance Reports (APR)
- Clinical/Diagnostic Performance Documentation
- Benefit-Risk Analysis Documentation

- Coordinate activities related to IVDR product classification and conformity assessment requirements.
- Ensure products comply with applicable General Safety and Performance Requirements (GSPR) under EU IVDR.
- Support IVDR transition projects and ensure products remain compliant throughout the regulatory lifecycle.
- Liaise with Notified Bodies, Authorized Representatives, Competent Authorities, and external consultants regarding regulatory submissions and compliance activities.
- Monitor global regulatory changes and assess their impact on existing products and registrations.
- Support maintenance of EUDAMED-related documentation and regulatory records as applicable.

Audit & Compliance





- Support ISO 13485, IVDR, MDSAP, customer, and regulatory audits.
- Participate in Notified Body audits and support timely closure of audit observations.
- Ensure audit readiness by maintaining complete and compliant quality and regulatory documentation.
- Drive compliance initiatives and promote quality awareness across departments.

Required Skills & Experience:

- 3–5 years of experience in QA/RA within the IVD industry.
- Mandatory hands-on experience with EU IVDR (Regulation (EU) 2017/746).
- Experience in preparation and maintenance of IVDR Technical Documentation, Performance Evaluation Documentation, and PMS-related records.
- Robust understanding of EU IVDR requirements including:
- Annex II & III Technical Documentation
- GSPR Compliance
- Performance Evaluation
- PMS & PMPF
- Vigilance Reporting
- Risk Management
- Product Classification
- Conformity Assessment Processes

- Working knowledge of ISO 13485:2016 and ISO 14971.
- Experience in complaint handling, CAPA management, change control, and regulatory submissions.
- Exposure to interactions with Notified Bodies and regulatory authorities.
- Strong documentation, analytical, communication, and cross-functional coordination skills.

Preferred Skills / Additional Knowledge

- ISO 13485 Internal Auditor or Lead Auditor Certification.
- Experience supporting IVDR certification and transition projects.
- Exposure to MDSAP requirements and audits.
- Knowledge of US FDA 21 CFR Part 820/QMSR requirements.
- Experience in global regulatory registrations for IVD products.
- Six Sigma Green Belt/Black Belt certification will be an added advantage.
- Familiarity with EUDAMED and international regulatory frameworks.

📌 Quality Assurance & Regulatory Manager (Navi Mumbai)
🏢 Trivitron Healthcare
📍 Navi Mumbai