台灣安麗莎醫療器材科技股份有限公司

1. Proactively track regulatory updates and develop strategies to ensure product design meets associated requirements 2. Closely work with R&D department to generate and maintain technical documents 3. Actively coordinate the schedule for pre-market submissions (FDA/TFDA/CE mark) and prepare/review documents for submissions 4. Effectively communicate with competent authorities to accelerate product approval 5. Efficiently collaborate with testing labs or consultants to ensure the product meets associated testing standards or official guidances 6. Support internal and external QMS audit 7. Other duties as assigned

1. Proactively track regulatory updates and develop strategies to ensure product design meets associated requirements 2. Closely work with R&D department to generate and maintain technical documents 3. Actively coordinate the schedule for pre-market submissions (FDA/TFDA/CE mark) and prepare/review documents for submissions 4. Effectively communicate with competent authorities to accelerate product approval 5. Efficiently collaborate with testing labs or consultants to ensure the product meets associated testing standards or official guidances 6. Support internal and external QMS audit 7. Other duties as assigned