Medical Device Registration Officer

• Prepare, collect, and verify technical documents to submit medical device registration applications to the Food and Drug Administration (FDA), including notification, detailed notification, and licensing types.

• Track application status and perform corrections or provide additional clarifications as requested by FDA officers to obtain licenses within the specified timeframe.

• Verify the accuracy of Labels and Instructions for Use (IFU) to ensure compliance with FDA regulations.

• Renew licenses and various certificates related to the import and distribution of medical devices.

Qualifications: Bachelor's degree Female, aged 25 years and above 1-3 years of experience in medical device registration (Regulatory Affairs) Proficiency in English, able to read and understand content in documents Able to complete assigned tasks within the specified timeframe High attention to detail in document verification, high responsibility, and ability to multitask Enthusiastic and ready to learn new things Good communication and coordination skills, and able to solve immediate problems effectively Understanding of government-related processes, able to control emotions and work under pressure Able to work from home, but must attend progress report meetings at the company at least once a week