Regulatory Affairs Officer, Medical Devices
Địa điểm làm việc: Hà Nội
Chức vụ: Nhân Viên
Hình thức làm việc: Mọi hình thức
Yêu cầu giới tính: Không yêu cầu
Yêu cầu
• Bachelor’s degree or equivalent, in science. Open to fresh graduates with working experience as RA internship role.
• Proficient in Microsoft Office applications especially excel files.
• Independent. Highly result oriented; ability to deliver and overcome obstacles
• Effective interpersonal, communication and analytical skills
• Proficiency in written and spoken English.
Quyền lợi
Will be discussed in the interview
Chi tiết
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
