Regulatory Affairs Project Specialist - Abbott Medical Devices

QUALIFICATIONS: Describe the minimum education and experience, including knowledge, skills and abilities, required to successfully perform the job. List any certificates and/or registration required.

• Diploma, Advanced/Higher/Graduate Diploma, Bachelor’s degree or equivalent, in science.

• 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.

Discuss during interview

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/support 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