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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

Duties:


    • 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

 

Requirements:


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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