Regulatory Affairs Specialist

Location Singapore
Discipline Healthcare & Medical
Job Reference BBBH106782_1635735671
Salary AWS
Consultant Name Song Zhaohui
Consultant Email zhaohui.song@manpower.com.sg
Consultant Contact No. 62328817
EA License No. 02C3423
Consultant Registration No. R1761205


Responsibilities:

  • Managing regulatory affairs activities for company including products registration and other approvals required to conduct current and future business activities.
  • Liaise with teams to develop plans, cost estimates, and acquiring the necessary permits and other approvals.
  • Establishing a close professional relationship and maintaining active dialog with relevant health authorities
  • Ensuring regulatory and quality assurance compliance according to SOPs.
  • Plan, lead and maintain GDPMDS program as the Management Representative to meet with QMS qualifications.


Requirements:

  • Degree in Biomedical Engineering or equivalent
  • Minimum 3 years of experience in RA management in Medical Device industry
  • Experience in GDPMDS and possess knowledge of Medical Device Regulations

Song Zhaohui EA License No. 02C3423 Personnel Registration No. R1761205

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