Upper Mckinley, Taguig


    Assist the QA department in administering and compliance with FDA and must be knowledgeable in risk classification on drugs.


    • Classifies all ADD products according to Risk Classification.
    • Prepares and reviews documents for submission to FDA and NRL.
    • Assists with the conduct of Performance Evaluation for DOA (Drug of Abuse), HCV, HIV, HBV, Syphilis, Anti-HBs, Anti-HBc IgM, Anti-HBc II, HBeAg, Anti-HBe and HBsAg Confirmatory tests.
    • Create letter to notify FDA for the amendment of documents regulated products.
    • Follow up with NRL for the endorsement of FDA for the conduct of Performance reports of Performance evaluation.
    • Check FDA website for the status of regulated products for Certificate of Registration.
    • Follow up FDA for the release of Certificate of registration of regulated products.
    • Review and file all authenticated documents.
    • Comply to Quality and Regulatory document requirements.
    • Update the regulatory information system on valid Certificate of Exemption and Certificate of Product registration.
    • Organize files.
    • Perform other duties as assigned.


      • Must be a graduate of BS in Medical Technology
      • Must be unlicensed/underboard or not taking the Med Tech Board Examination