職務要求

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

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