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

Quyền lợi được hưởng

13-month salary & performance bonus
,#Premium Healthcare
,#Training & Development

Yêu cầu kỹ năng

Regulatory Affair, Đăng Ký Thuốc, Thiết Bị Y Tế