Muruga Boopathi Ravi

About Muruga Boopathi Ravi

Life Sciences professional with over 4 years of experience across Pharmacovigilance, Post-Market Surveillance, Vaccine R&D, and Pharmaceutical Microbiology. Skilled in Drug Safety operations, safety data review, regulatory compliance (GxP, ICH-GCP), and SOP-driven quality processes. MSc Microbiology graduate with a strong analytical mindset and a compliance-focused approach.

Experience

1. Pms Analyst (Compliance Handling)

   HCLTech

   Apr 2025 — Present

   As a Post-Market Surveillance (PMS) Analyst, I am responsible for evaluating, analysing, and processing customer-reported cases related to medical devices. My role ensures regulatory compliance by assessing each case for complaint validity, documenting it in the appropriate systems, and coordinating necessary submissions to global regulatory authorities.Key Responsibilities: • Perform end-to-end case handling activities for post-market product issues received from clients. • Review incoming cases and determine whether they are Complaint or Not a Complaint as per internal procedures and global regulatory guidelines. • Log, update, and manage cases accurately in Salesforce and TrackWise systems. • For valid complaints, classify the case appropriately and initiate the Medical Device Reporting (MDR) process. • Prepare, review, and route MDR submissions to the US FDA, ensuring high accuracy, compliance, and timely submission. • Collaborate with cross-functional teams (Quality, Regulatory, Safety, and R&D) to collect additional information when required. • Maintain strict adherence to SOPs, Work Instructions, ISO 13485, and FDA 21 CFR Part 803 requirements. • Ensure all case documentation is complete, traceable, and audit-ready. • Support periodic audits, CAPA activities, and compliance assessments related to PMS. • Contribute to continuous improvement initiatives within the PMS and Compliance functions.Tools & Platforms: • Salesforce • TrackWise • Internal Quality Management Systems (QMS)Regulatory Exposure: • US FDA MDR (Medical Device Reporting) • ISO 13485 • EU MDR (basic understanding)Core Skills: • Complaint evaluation & decision making • Regulatory compliance understanding • Case documentation • Attention to detail • Analytical thinking • Strong written communication

Education

• Sri Krishna Institute Of Technology

  Bachelor of Science , Microbiology, General

  2018 — 2021

• Bharathiar University

  Master's degree, Microbiology, General