Manage regulatory requests for APAC countries, including new product registrations, license renewals, and release of new products into markets Perform regulatory assessments in Supplier Change notificationsDraft and edit Device Master files and Plant Master filesCoordinate with third party suppliers for regulatory submissions Analyze current procedures and identify potential causes for process delays, make edits to procedures based on findings to increase efficiency

Handled all International Regulatory requests from EU, China, Japan, Australia, and New Zealand, including New product registrations (reviewing and drafting submission documents), license renewals and updates, Heath Authority notifications, distribution of regulatory documentation, and release of new products into markets Managed all regulatory submissions and activities for Australia, both NPI and LCM Drafted and edited Product Information Leaflets and Product Information Cards for TGA submissionsOrganized license extensions for China licenses Maintained regulatory databases Assisted with the update and maintenance of EU technical files and STEDs

Oversaw the management of the Regulatory Database on Microsoft Access Developed training for any future user or editor of the Regulatory Database Executed regulatory license registrations and renewals for waters medical devices in US, Canada, Japan, Taiwan, Colombia, Malaysia, and China Prepared and filed Various FDA reports such as the annual Radiation Emitting Products Report Assisted with medical device recalls and Field Actions, reviewed scientific papers to ensure compliance with promotional guidelines Worked closely with coworkers from other departments to help write company-wide procedures. Coordinated with cross-functional team members in assembling summary technical documentation to facilitate international registrations