Kayal Vizhi

I am an aspiring professional transitioning into a Senior Analyst role within the regulatory services industry. With a strong foundation in global device and diagnostics regulations and hands-on experience in regulatory intelligence, I bring strategic insights to support informed regulatory decision-making. My focus lies in driving innovation and ensuring compliance through detailed research, data analysis, and regulatory expertise, aligning closely with the organization's mission to deliver outstanding regulatory services.

Over 3 years of experience in global regulatory services with a focus on device and diagnostics regulations including EU, US, and Canada. Proficient in medical writing with an emphasis on Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER). Experienced in technical file writing, dossier submission, and compliance monitoring to meet stringent industry standards. Demonstrated adaptability and problem-solving skills in fast-paced, cross-functional team environments. Strong background in internal audits, CAPA processes, and ISO 13485 certification to ensure quality management system compliance.

B.E Biomedical Engineering in Dhana Lakshmi Srinivasan Engineering College, completed at 2019