Amy Yang

Implement regulatory affairs programs for Worldwide Regulatory Strategy and Compliance. Product Categories: FDA Class 1 and 2, CE Class I, IIa and IIb Devices – Patient Monitoring, Electrocardiography, Stress Exercise, Holter and Oximetry. All devices include software components and several software only associated products. Geographic Responsibility – US, Canada, EU, Australia, Brazil, China, Japan, Russia, Middle East, South and Central America, Eastern Europe and Asia. Prepare premarket approval strategies and submissions (US and International). Completed several Class II 510(k)’s. Experienced in US FDA 510(k) Premarket Notifications, Canadian Licensing, EU Documentation and International registration and submissions. Provide comprehensive business and product information to worldwide peers for product introductions and training. Provide product and test information to support international submissions. Generate and maintain custom Dossiers with country requirements for new registrations, responses, renewals, and tenders to support compliance with regulatory requirements. Perform Internal Audits of Quality System, participates in regulatory as well as supplier audits performed by external auditors for compliance to regulations and harmonized standards. Maintain UL/CSA/INTERTEK Product Inspection reports/ files. Acts as liaison for UL/CSA/INTERTEK inspection/ follow-up activities. Transferred acquired products regulatory files and filings to Mortara Instrument for US, Canada, EU and Australia. Participated in large acquisition and functioned as Project Manager for design and manufacturing transfer of 6 products to Mortara Instrument design control and manufacturing processes.

Responsible for internal validation activities, and participate in the planning, procedure and execution of product (software) validation. Mentor and coach personnel new to validation activities to fulfill requirements specified in each project. Strong knowledge of the FDA CFR, ISO 13485, MDD Standards, regulations, and guidelines. Provide assistance with FDA 510(k) Premarket Notifications or related documents, as well as audits performed by customers and regulatory bodies.