Parivallal P

WORK HISTORY

EDUCATION

ABOUT PARIVALLAL P

Quality Engineer & Regulatory Affairs Specialist:• Prepared Risk Management Plans, Hazard analysis, Risk analysis Charts, Design and user FMEA for Hardware, Console and Software products and the report for residual disclosure as a part of EU-MDR Remediation adhering to ISO 14971:2019 standard.• Creation of Design History File [Design and Development Plan, Design input, Design Verification, Design output] documents for the Lung Diagnostic device.• Performed complaint analysis to ensure the product needs/does not need an lIA or risk zone up classification.• Frequent collaboration of the cross-functional team and timely review to support the development/ remediation of Design control documents to comply with Regulatory requirements.• Co-authored and reviewed Post Market Surveillance reports and analysis on the same.Supplier Quality:• Supplier Quality is responsible for managing external suppliers throughout the product lifecycle, including evaluating and qualifying suppliers, monitoring supplier performance, auditing suppliers\' quality management systems against applicable regulations and quality standards, providing metrics, and addressing quality and regulatory issues. Experienced Regulatory affairs candidates with a demonstrated history of working in the regulations of US FDA and EU MDR guidelines.Skilled in Risk management, Gap assessment, Standard assessment as per ISO 13485, ISO 14971 and ISO 10993 standards. Experienced in medical devices complaint handling, reporting and trending in Track Wise tool.Familiarity with FDA 21 CFR 820, 21 CFR 803 and other medical device regulations.Skilled in US FDA, EU MDR, MQMS 13485, Risk management.