Regulatory Affairs Project Specialist, Medical Devices
Abbott
02 Ngo Duc Ke, Dist. 1, HCM
Hết hạn
Xóa tin
Chi tiết tuyển dụng
Mức lương:
Thỏa thuận
Khu vực:
Hà Nội
Chức vụ:
Nhân viên
Hình thức làm việc:
Toàn thời gian
Lĩnh vực:
Khác
Mô tả công việc
DIRECT REPORTING TO:
Regulatory Affairs Manager
KEY PURPOSE OF ROLE:
Responsible for Regulatory Affairs activities / projects. Supports in EU MDR related submission, approval and related projects in Malaysia, Vietnam, Indonesia or any assigned geographies. Implements regulatory plan for earliest possible approvals.
KEY RESPONSIBILITIES:
• Handle/supports compilation of dossiers, submission and follow up for approvals for Registration of Medical Devices.
• Ensure proper documentation and record management of submission, approvals, certificates as required.
• Monitor requirements of related medical device laws & regulations
• Supports in regulatory related processes or projects, e.g. labeling project, GTS process
Regulatory Affairs Manager
KEY PURPOSE OF ROLE:
Responsible for Regulatory Affairs activities / projects. Supports in EU MDR related submission, approval and related projects in Malaysia, Vietnam, Indonesia or any assigned geographies. Implements regulatory plan for earliest possible approvals.
KEY RESPONSIBILITIES:
• Handle/supports compilation of dossiers, submission and follow up for approvals for Registration of Medical Devices.
• Ensure proper documentation and record management of submission, approvals, certificates as required.
• Monitor requirements of related medical device laws & regulations
• Supports in regulatory related processes or projects, e.g. labeling project, GTS process
Quyền lợi được hưởng
13-month salary & performance bonus
,#Premium Healthcare
,#Training & Development
,#Premium Healthcare
,#Training & Development
Yêu cầu kỹ năng
Regulatory Affair, Đăng Ký Thuốc, Thiết Bị Y Tế
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