Regulatory Affairs Associate

Petaling Jaya, Selangor, Malaysia

Job Description

  • Preferred 1year of Regulatory Affairs experience in the Medical Device industry
  • Candidate must be willing to travel (locally -for submission purpose only)
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
  • Annual Leave
  • Medical Leave
Additional Benefits
  • 5 Working Days

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Job Detail

  • Job Id
    JD850537
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Petaling Jaya, Selangor, Malaysia
  • Education
    Not mentioned