「海洋保育」找工作職缺 | 政府出版品書目資料查詢網

1. Plan, organize and implement regulatory strategies to for products in development and for modified products to achieve clearance/approval internationally (Taiwan, US, Japan, and Southeast Asia, etc.) 2. Prepare and review registration files for medical devices, such as new medical AI software and / or software modification as required to ensure timely clearance or approvals. 3. Maintain regulatory submission timelines and track deliverables to ensure company goals are met. 4. Provide regulatory input to product development teams, including products’ regulatory pathway and anticipated approval timelines. 5. Write and edit clinical development documents, including but not limited to, clinical protocols, investigators brochures, clinical study reports, clinical evaluation report, and master inform consent forms. 6. Provide suppo...