Kesava Raj Murugan

About Kesava Raj Murugan

I am a Senior Quality & Regulatory Specialist-MD/IVD (Immediate Joiner) with overall 8+ years of experience including 7 years in MedTech industry across post-market surveillance, complaint handling, regulatory compliance, and design quality. I specialize in ensuring global compliance across EU MDR/IVDR and US FDA regulations, while driving quality excellence throughout the product lifecycle. In my current role of QARA, I have managed end-to-end MD/IVD products, capital equipment and IVD instrument complaints across global markets, achieving zero delays in vigilance reporting (MDR/MIR) and consistently maintaining audit-ready documentation. I have successfully reduced complaint cycle times, improved First-Time-Right (FTR) quality, and strengthened CAPA effectiveness through data-driven decision-making and cross-functional collaboration. My experience spans: • Post-Market Surveillance & Complaint Handling (Intake to Closure) • Regulatory Compliance (EU MDR 2017/745, IVDR 2017/746, US FDA 21 CFR) • Risk Management (ISO 14971) & QMS (ISO 13485) • Design Verification & Validation (DHF, DVP, Test Methods) • Technical Documentation & Materials Compliance (CMR, ED, REACH, RoHS) I have also contributed to DHF remediation, shelf-life studies, and regulatory technical file development, delivering projects ahead of timelines with high accuracy. Known for strong stakeholder communication and leadership, I’ve trained and mentored teams, improving documentation quality and reducing rework rates significantly. I am passionate about patient safety, regulatory excellence, and continuous improvement, and I thrive in roles that bridge quality, regulatory, and engineering domains.

Experience

1. Senior Member of Technical Staff

   HCLTech

   Oct 2018 — Present

   I excel in quality assurance and regulatory affairs, focusing on compliance and process improvement in the medical devices industry. • Developed technical documentation and managed complaint handling processes to ensure regulatory compliance. • Strengthened audit-ready quality systems, enhancing the effectiveness of CAPA processes across teams. • Recognized for reducing complaint cycle times, contributing to streamlined regulatory submissions and improved product lifecycle management.

Education

• Sri Ramanujar Engineering College

  Bachelor of Engineering - BE, Mechanical Engineering