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Regulatory Affairs Specialist job in Pioneer at MP Biomedicals Asia Pacific Pte Ltd

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Regulatory Affairs Specialist at MP Biomedicals Asia Pacific Pte Ltd

Regulatory Affairs Specialist

MP Biomedicals Asia Pacific Pte Ltd Pioneer Permanent

Basic Functions:

  • Support in new product registrations, variations, and renewals for MP AP's products


  • Prepare documents for registration to countries
  • Co-work with sales/marketing for providing documentation supports to countries
  • Maintain registration dossier properly
  • Support in updating CE technical documents annually
  • Assist in Notified Board audit and review
  • Ensure the registration database is updated and inform the relevant departments for any changes
  • Monitor global regulations/standards actively
  • Verify the labelling accurately per regulatory requirements
  • Assist in internal/external audit


Ability to:

a. Understand how to review technical documents and provide feedbacks to R&D if there is any regulation update

b. Compile the registration documents correctly and efficiently

Knowledge of:

a. Regulations/standards for medical devices/In vitro diagnostics

b. Technical terminology used in the laboratory

Education: Basic Science Degree

Experience: 1-2 years in RA/QA or in medical device/IVD industries

Recommended Skills

  • Audit
  • Compliance
  • Iso
  • Legislation
  • Surveillance
  • Terminology
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