Mohan Rajan

About Mohan Rajan

Lead and manage the Quality Assurance and Regulatory Affairs (QARA) team for medical…

Experience

1. Deputy Manager Quality Assurance and Regulatory Affairs

   IATOME ELECTRIC (I) PVT LTD

   Dec 2024 — Present · Coimbatore, IN

   Lead and manage the Quality Assurance and Regulatory Affairs (QARA) teams for medical X-ray equipment manufacturing. Allocate and monitor daily tasks across Quality and Regulatory teams to ensure compliance and productivity. Drive resolution of customer complaints—warranty, infant failure, and early-life product issues—through root cause analysis and implementation of corrective actions. Ensure Quality and Regulatory activities in New product Development from M0 to M5 Phase. Ensure Risk review as per ISO 14971 at all stages of product life cycle. Supported for Development, Implementation and sustaining of change management software. Manage regulatory compliance activities in line with CDSCO MDR 2017 requirements, including license applications for MD7, MD9, MD12, MD15 certifications. Maintain ISO 13485 Quality Management System throughout the organization. Ensure ISO 17025 compliance within the in-house X-ray testing laboratory. Comply with Atomic Energy Regulatory Board (AERB) protocols and standards for radiation-emitting equipment. Conduct weekly strategic QARA meetings with senior management to review performance and compliance status. Develop and report departmental KPIs for continuous improvement and audit readiness. Regulatory activity involves license activity of CDSCO, BIS, AERB, NABL protocol. Attending external audits for ISO13485, NABL, BIS and Customer audits.

Education

• Annamalai University

  Bachelor of Engineering (B.E.)

  2005 — 2009