Regulatory Affairs Officer, Medical Devices

• 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.

Will be discussed in the interview

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