Linda Locke

Senior Director - Regulatory and Quality @Corentec Co., Ltd

Shelby County, TN, US

Advisor to senior executives within the organization for matters related to FDA regulatory and Quality compliance. Serve as liaison between legal manufacturer, initial importer, and US Agency. • Collaboration and communication with cross functional leaders and team members to ensure products and processes meet FDA regulatory requirements.• Implement and maintain QMS for initial importer including document control and complaint files.• Execute and lead QMS training program.• Advise and direct medical device reporting per 21 CFR Part 803.• Support HHE and CAPA compliance.• Oversee supplier management program including assessments and agreements.• Serve as SME contributor for new product development, regulatory files and 510k submissions.