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Regulatory Officer

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Regulatory Officer

  • Location:

    Cubao, National Capital Region

  • Sector:

    Monroe Health

  • Job type:

    Permanent

  • Salary:

    Up to £575000.00 per annum

  • Contact:

    Fervin Jay Gumban

  • Contact email:

    fervin.gumban@monroeconsulting.com.ph

  • Job ref:

    BBBH408106_1668157993

  • Published:

    26 days ago

  • Expiry date:

    2022-12-11

  • Client:

    Monroe Consulting Group


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

  • Graduate of Bachelor of Science in Pharmacy.
  • Registered Pharmacist with unexpired PRC (Professional Regulation Commission) ID.
  • Preferably with working experience: at least one (1) year of experience in the related field.
  • Excellent organisational and planning skills.
  • Strong sense of responsibility. Must work with minimal supervision and direction, resourceful, and can work under pressure.
  • Above average computer skills.
  • Good communication. Ability to multitask, organise, attention to details and accuracy.