RA Specialist

Responsibilities ⦁ Compile and submit new product registrations, QSD registrations, license extensions, variations, and renewal according to the submission plan, and ensure approvals in a timely manner. Maintain and archive regulatory files in a format consistent with requirements. ⦁ Provide regulatory support to internal/external customers. ⦁ Assist and work with logistics to maintain the logistic-RA related database, procedures and systems. ⦁ Support to maintain regulatory database in GTS, SAP systems. Support to maintain the UDI information to TFDA TUDID. ⦁ Support to maintain the Chinese labelling database and Chinese labelling activities. ⦁ Support the product complaints handling, AE, quality field actions, recalls and PMS data collection or reporting in Taiwan. ⦁ Support to mapping the latest regulatory and corporate requirements concerning quality and quality systems. Update the necessary processes and procedures for Taiwan. ⦁ Support to maintain ISO 13485, QMS, GDP quality system.