About this role
Regulatory Officer is to act as the representative/point person in ensuring that the company is compliant with all the applicable regulations, particularly for product registration, by any of the authority agencies in Philippines.
1. Process License to Operate (LTO) such as apply for initial LTO as importer and distributor of medical devices to any agencies applicable to company and renew existing LTO's for FDA, NTC and OMB.
2. Renew and change Certificate of Medical Device Notification/Registration (CMDN/CMDR) prior to expiration and apply CMDN/CMDR to all existing and new products.
3. Handle Brand name Registration
4. Provides Marketing Support documents
5. Safekeeping, organizing and filing of Documents
6. Liaise and coordinate with Principal Relations
7. Process requirements for Regulatory Agencies
Graduate of BS PharmacyMust be a licensed or registered pharmacistAt least 2 years' work experience in regulatory industry preferably in Medical Devices & IVD DivisionExperienced in dealing with FDA CDRRHR or Medical DevicesKnowledgeable and updated with government mandates related to medical devices most especially FDA AO No. 2018-002Have attended at least once the Licensing Seminar for Medical Device EstablishmentsKeen to details specially with documents assessmentGood communication skills (written and oral) specially with Principals/Business partners especially in relation to documentary Requirements for CPR processingProficient in MS Applications 75% - work on site (Pasig Office)
20% - field work (FDA/NTC/OMB/RITM)
5% - reporting at warehouse (very minimal)