Job description

Job description

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.

Requirements:
Bachelor’s degree in Science or related discipline.
Good knowledge in Malaysia Medical Device Regulation
Preferred 1year of Regulatory Affairs experience in the Medical Device industry.
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)
Established in 1996, we have grown to become a leading recruitment consultancy firm with 14 offices in Singapore and footprints in Hong Kong, Kuala Lumpur and Taipei. 2017 is a significant year for us as we get listed on the Singapore Stock Exchange.

Our Mission: We Help People Find Good Jobs and Our Clinets to Succeed in Business.

Our Vision: To Be The Leading and Most Admired Recruitment and Staffing Consulting Firm in Singapore and Asia Pacific.
Diploma / Advanced Diploma / Higher Graduate Diploma / DVM / DKM Level 4 / DLKM Level 5

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