Sanjay T N

WORK HISTORY

EDUCATION

ABOUT SANJAY T N

Senior Quality & Regulatory professional with over 8.5 years of experience inthe medical device industry across V&V, usability engineering, complainthandling, CAPA, and post-market surveillance. I have strong expertise in globalregulatory and quality standards including FDA regulations, ISO 13485, 21 CFRPart 820, and IEC 62366, with a proven track record of improving auditreadiness, product quality, and patient safety. I specialize in root causeanalysis, risk management, and QMS process improvement while leadingcross-functional collaboration with R&D, manufacturing, regulatory, andquality teams. Known for delivering compliant, data-driven solutions, Icontribute to continuous improvement and operational excellence inhealthcare technology environments.Technical Role:• Served as a Complaint Handling Specialist with expertise in end-to-endprocesses including Evaluation, GDT, Investigation, and VigilanceReporting.• Demonstrated proficiency in Risk Management methodologies such asPFMEA, DFMEA, and uFMEA• Skilled in creating and maintaining compliance documentation, includingSOPs, Device History Records (DHR), and Quality Plans (QP)• Applied Quality Tools such as Pareto Charts, Flow Charts, and Cause & Effect Diagrams to drive process improvements and operational efficiency.• Hands-on experience with X-Ray Vascular devices (Class 2a) and MR Table,with strong knowledge of IGT Systems.• Extensive experience in end-to-end CAPA activities, ensuring timelyclosure and regulatory compliance.• Participated in internal audits and MDSAP audits, contributing tosuccessful compliance outcomes.• Expertise in Usability Engineering, including Formative and SummativeStudies for medical devices.Management Role:• Led and managed a team of 15 members, ensuring smooth operations andhigh performance.• Successfully handled client interactions across EU and US regions,maintaining strong stakeholder relationships.• Conducted training sessions for new joiners and facilitated brainstormingdiscussions to resolve team challenges and improve efficiency.• Successfully onboarded and monitored new joiners, ensuring timelytraining sessions were conducted and providing necessary guidancethroughout the process.• Ensured all KPIs were met in line with client expectations and maintainedrecords with a “First Time Right” approach