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.