Công ty Cổ phần Thế giới Phụ nữ

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

• 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.

Thưởng
13-month salary & performance bonus
Chăm sóc sức khoẻ
Premium Healthcare
Đào tạo
Training & Development