Boopathy Mayilsamy

I am a Biomedical Engineer with over 3.8 years of experience as a Regulatory Analyst at HCL Technologies. My focus has been on medical device complaint management and ensuring regulatory compliance. I am well-versed in MDR submissions, risk assessment, and quality system standards, including ISO 13485 and 21 CFR 820. My role has allowed me to develop strong skills in defect analysis, root cause identification, and preventive action strategies.

Throughout my career, I have managed the end-to-end complaint handling process, from intake to closure, and have led risk management activities aligned with ISO 14971. I have consistently received positive feedback for my documentation accuracy and process adherence during internal audits. My contributions have improved team efficiency, reducing defect rates by 69%, and I have played a key role in workflow automation initiatives. I thrive in collaborative environments, working with cross-functional teams to conduct in-depth investigations and ensure compliance with regulatory expectations.