醫療器材法規專員 (Regulatory Affairs Representative)

Updated 22 days agoBio, Medical » Other

Job Description

1. 國內外醫療器材法規認證事務及相關法規、標準之收集與更新。

2. 負責公司醫療器材產品在各國醫療器材查驗登記相關送件、維護及變更。

3. 協助公司ISO13485/QSR及相關品質系統建置及稽核。

4. UDI系統的建立、登記、管理。

5. 協助產品驗證之法規諮詢。

6. 合作專案管理及協助業務部門日常管理。

Requirements

.大學以上畢業

.相關工作經驗1年以上

1
532K ~ 700K TWD/year
Partial Remote Work

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神經元科技股份有限公司

106 台北市大安區忠孝東路四段320號2樓

About us

Neurobit is dedicated to providing a solution -- A portable, wireless, eye movement/ nystagmus recording and analysis solution for assist in the diagnosis before neuroimaging. When the medical imaging database established via artificial intelligence, we can make early detection and rapid screening which can differentiate between peripheral nerve diseases and central nerve diseases.

Team

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