Regulatory Affairs Specialist

1 week ago

Giza, Giza, Egypt AMICO Group Full time

Job Purpose

Under general direction of the Regulatory Affairs Manager, the RA Specialist will do the required registrations

online and all related job requirements including communication with both teams at the supplier's side and inside Amico.

Key Responsibilities

  • Understanding the registration requirements for several countries
  • Requesting suppliers to provide different documents required for the registration
  • Feeding the different governmental systems with the required registration information and uploading needed documents.
  • Understanding the Comments received from the Authorities on any registration and passing it to the supplier in an easy understandable manner.
  • Attending Conference calls with suppliers, prioritizing the requirements, conveying the needed tasks in an understandable manner
  • Maintaining the Archive system
  • Ability to bridge the communications between Authorities/our local agents in the countries with the supplier
  • Follow the internal regulations in Amico
  • Other regulatory activities such as classification, prequalification and recalls
  • Communicating with the legal department in Amico for all legal concerns.
  • Update the SOPs related to our processes when needed
  • Close follow up for all pending issues
  • Preparing reports related to the progress of work

Job Requirements

  • Bachelor's degree or equivalent in Biomedical Engineering, Science or any relevant.
  • 3 years of experience in Regulatory Affairs with regional company (wide range of products)
  • Worked for Medical Device Registration outside Egypt or to register Egyptian products with other countries
  • Excellent Knowledge of MS Office.
  • Fluent in English language
  • Knowing the Pharmaceutical registration process
  • Previous experience in registrations in the Gulf will be an added value
  • Having a certificate in Quality or Regulatory Affairs will be an added Value

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