Executive recruitment company Monroe Consulting Group Philippines is recruiting on behalf of a reputable national medical device company. Our client is looking for a Regulatory Officer that will focus on processing documents for the company's licenses and clearance for Medical Device & Drug Importers. The position operates mostly on the field and directly reports to the Regulatory Compliance Manager.
Job Responsibilities:
Regulatory
- Responsible in processing of Initial, Renewal and Amendment registration of License to Operate for Medical Device & Drug Importer
- Prepare, classify and review the submission of dossier of all technical documents for the new registration application of company's products for the upcoming regulation of Administrative Order No. 2018-002
- Application and Processing of:
- Performance Testing of Single-photon emission computed tomography and computerised tomography imaging machine/equipment
- Company's clients for the Initial/Renewal of a License to Operate (For X-Ray Facility)
- Clearance for Custom Release for radiation emitting devices
- Permit to Construct in Department of Health when necessary
- Initial/Renewal of Philippine Association of Medical Device Regulatory Affairs Professionals accreditation membership.
- Addition & Deletion of List of Sources/Suppliers
- Communicates with the principal supplies to request for Technical & Legal document needed for product registration
- Process the renewal for registration and notification of medical devices
- Update the company with the new regulations
- Attend the initial & follow-up inspection of company's office and its accreditation to Operate as distributor/importer of Medical Device and Drug
- Represent the company to attend Food and Drug Administration seminars as well as attend Annual General Membership
Optical Media Board
- Preparing documents for Initial, Renewal, Amendment needed for Initial, Renewal of company's Six (6) Licenses to Operate Optical Media Business
- Application and processing requirements of import permit prior shipment in every Purchase Order of Importation for Custom Clearance purposes
- Represent the company to attend Optical Media Board Seminars
National Telecommunications Commission
- Deal with Initial/Renewal (Yearly)/Amendment of Dealers Permit for Wireless Data Network Equipment & Devices
- Conduct registration and application of Import Permit of equipment, parts, & accessories for custom clearance purposes (Every Purchase Order/Importation)
- Prepare and Submit Monthly Stocks Report
- Prepare Purchase Request Form for retainer fee, documents for amend & yearly renewal of license
- Request documents from Human Resources when necessary
Philippine Government Electronic Procurement System
- Handle application for initial and renewal application by preparing documents needed for updated yearly attachment
Philippine National Police - CLEARANCE PERMIT
- Application & processing of License to Deal & Purchase of Controlled Chemicals, Permit to Import Controlled Chemicals for Custom Clearance (every importation), and Permit to Unload (every shipment)
Fire Safety Certificate
- Application of Initial/Renewal/Amendment Fire Safety Certificate of company's lab
Department of Environmental and Natural Resources
- Application & processing of Pollution Control Officer Training accreditation (Lab Personnel)
Other tasks
- Handles all application, documentation, processing needed for company to be compliant & updated on all regulatory requirements mandated by the government
- Primary contact with all the principal companies as far as securing all necessary required documents for licensing and registrations.
- Assist company's clients in the application of processing of license to operate of medical systems and equipment sold by the company to the customers.
- Monitoring the validity of company's Licenses & Permit & Principal Suppliers
Job Requirements
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