Regulatory Affairs Specialist, Medical Devices

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

• Ngày làm việc: T2 - T6 • Giờ làm việc: 9:00 - 18:00 • Cấp bậc: Nhân viên (associate) • Loại công việc: Toàn thời gian