Job Description

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)

Industry

Healthcare

Specialization

Administrative Support / Secretarial

Location

Selangor

Employment Type

Contract / Temp

Salary

MYR 2, 501 - MYR 3, 000 / mth

To apply online please click the 'Apply' button below. For email a detailed resume in Word format to Amanda Loo.

For further discussion about this role, please find contact details of Amanda Loo as below:
Email: amanda.loo@recruitexpress.com.my
Tel: 0327138830
*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.