Tuyển dụng Regulatory Affairs Specialist, Medical Devices tại Hà Nội

Main Purpose of Job:

Responsible for activities which lead to and maintain regulatory approval to market devices. Works with various stakeholders such as labeling / global team for launch readiness.

Develops and implements strategies for earliest possible approvals.

Ensures timely preparation of submissions. Builds rapport with regulatory agencies. Anticipates regulatory environment change and manages the regulatory intelligence for new policy, regulation etc. as required.

Key Responsibilities:

• Manage the regulatory approval or registration of medical devices and license maintenance.

• Develop registration strategies, prioritizing assignments, implementing regulatory plan, and coordinating multiple projects and activities in accordance with strategic company objectives, submission plan and targets.

• Research and monitors regulatory requirements for assigned geographies / competent authority

• Monitor requirements of related medical device laws & regulations

• Cultivation of professional working relationships with competent authorities and local medical device industry association

• Review and approval of A&P materials to ensure compliance with local regulations.

• Ensure proper documentation and record management of submission, approvals, certificates as required.

• Handle/supports regulatory related processes or projects, e.g. labeling project, PRA process

Yêu cầu công việc

• Diploma, Advanced/Higher/Graduate Diploma, Bachelor’s degree or equivalent, preferrably in pharmacy, health sciences or related science background

Skills and Experience:

• 2 years experience in Medical Device Regulatory Affairs preferred.

• Proficient in Microsoft Office applications especially excel files.

• Effective interpersonal, communication and analytical skills

• Proficiency in written and spoken English and Local language.

• Independent. Highly result oriented; ability to deliver and overcome obstacles.

Quyền lợi

• Thưởng: 13-month salary & performance bonus
• Chăm sóc sức khoẻ: Premium Healthcare for individual & family members
• Đào tạo: Training & Development opportunities