法務專員_知名運輸公司 (3006911)

職責要求 

1.審查,撰擬及修改合約等各種法律文件及其相關事項處理 

2.提供法律諮詢, 舉辦法律訓練 

3.非訟, 訴訟案件等相關法律事務之處理 

任職資格 

1.大學以上，法律系所，具英文溝通能力 

2.具2年以上法律事務所或in-house法務經驗 

3.熟悉民法及公司法 

4.具國內或國外律師證加分

職責要求 

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 

任職資格 

1. Experience in leading or supporting FDA submissions is mandatory 

2. Experience in applying for TFDA submission is preferred 

3. ISO 13485 and ISO 14971 skill is a plus 

4. Excellent communication, planning, managing, and problem-solving skills 

5. Be able to work independently and collaboratively