醫療器材法規專員（Regulatory Affairs Specialist-Medical Device）

工作內容：

1. 規劃與執行醫療器材國際註冊策略（FDA、TFDA ）
2. 主導或參與 FDA submission（510(k)、De Novo）
3. 撰寫與整合 SaMD 技術文件（含演算法說明、驗證與臨床資料）
4. 與 FDA / TFDA 溝通審查意見並進行回覆（含 pre-sub）
5. 參與產品開發早期法規策略制定（classification、intended use、risk）
6. 蒐集並分析 AI 醫材相關法規（FDA AI/ML guidance）
7. 跨部門合作（研發 / Data Scientist / QA）
8. 支援臨床試驗法規規劃（如需要）

1. Develop and execute global regulatory strategies for medical devices (including FDA and TFDA submissions).
2. Lead or support FDA submissions, including 510(k), De Novo, and other regulatory pathways.
3. Prepare and compile technical documentation for Software as a Medical Device (SaMD), including algorithm descriptions, verification/validation, and clinical evidence.
4. Communicate with regulatory authorities (FDA / TFDA), including responding to review comments and managing Pre-Submission (Q-Sub) interactions.
5. Contribute to early-stage product development by defining regulatory strategies (e.g., device classification, intended use, risk assessment).
6. Monitor and analyze global regulatory trends and guidance related to AI/ML-based medical devices (e.g., FDA AI/ML guidance).
7. Collaborate cross-functionally with R&D, Data Science, and Quality Assurance teams.
8. Support regulatory planning for clinical studies, if required.