Upper Mckinley, Taguig
Assist the QA department in administering and compliance with FDA and must be knowledgeable in risk classification on drugs.
DUTIES AND RESPONSIBILITIES:
- 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