Kiswin Jinu G J

About Kiswin Jinu G J

Biomedical Engineer with an MBA in Marketing & Systems, specializing in Regulatory…

Experience

1. Post-market Surveillance & Complaint Handling Associate

   HCLTech

   Apr 2025 — Present · Chennai, IN

   As a Post-Market Surveillance (PMS) & Complaint Handling Associate, I am responsible for ensuring that the medical devices comply with regulatory standards, ensuring patient safety, and addressing complaints efficiently. In this role, I work closely with cross-functional teams, including regulatory affairs, quality assurance, and clinical operations, to investigate, track, and resolve product complaints.Key Responsibilities:Monitor, analyze, and report product complaints, ensuring compliance with medical device regulations.Perform Root Cause Analysis (RCA) to investigate and address product issues, ensuring corrective actions and improvements are implemented.Maintain and update detailed records of complaints and non-conformities using tracking systems (e.g, SAP, TrackWise).Collaborate with Regulatory Affairs (RA) and Quality Assurance (QA) teams to ensure adherence to local and international standards (FDA, ISO 13485).Prepare regulatory reports and support post-market clinical follow-up processes.Assist in handling vigilance reporting, including incidents and adverse events, and ensure timely submissions to regulatory bodies.Provide insights and recommendations for product improvements based on complaint data.