鸿图医疗招聘

职位描述：

• 辅助手术器械
• 光导手术器械
• 普通手术器械
• FDA
• SFDA
• CFDA
• ISO13485
• ISO14971
• 医学、生物及相关专业
• 英文可作为工作语言

職責笵圍(請詳細列明): 1. work with product development team to perform product. clinical evalualation for new product. 2. develpment and update the clinical information for marketed product. 3. Perform post market clinical follow-up studies for marketed products. 4. Update post production information for marketed products. 5. Update Regulatory and standards (FDA, Health Canada, EU) information every month. 6. Have leadership skill to lead the team to finish the product resgistration in CE 要求資格: 性別: 不限 年齡: 25-45 學歷:qualification: Bachelor or advanced degree in clinical, medicine, pharmacy, biomedical, or related discipline 相關經驗年資; at least 5 yrs experience in regulatory affairs 技能:Skills 1.rich experience in clinical study are preferred. 2. successful experience with clinical evaluation for CE registration. 3. Good ability to search literatures from the databases of EU or other countries. 4. Demonstrated in the active medical device regulatory standards and skillful in the standards with respect to the electrosurgical insturments.

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