Regulatory Affair Specialist, Medical Devices

Petaling Jaya, Selangor, Malaysia

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Preferred 3 to 5 years of Regulatory Affairs experience in the Medical Device industry.
MNC exposure is an added advantage.
Good English language and communication skills.
Experience in cross functional working in a matrix organization.
Candidate must be willing to travel (locally -for submission purpose only)
Can works independently with general supervision.

Responsibilities

Review, prepare, compile and submit all documentations required for medical device submissions, license renewal, new device registrations and change notification, import permit with relevant regulatory agencies (MDA, NPRA, SIRIM)
Manages and implements internal regulatory tracking / control systems.
Liaise with regulatory agencies on defined matters.
Work closely with Global RA partners to obtain registration documents.
File and maintain regulatory deliverables
Involve in GDPMD internal and external audit annually.
May be involved in cross functional assignments.
Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Any other related duties may be assigned from time to time.

Benefits

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