Omar Hassan

Experience

• 

  Modern Sciences and Arts University

  Sept 2016 - Jul 2020

  Board of Study Membership

  Contributing to the development of the educational process through meetings held with the Britishdelegation from Greenwich University to discuss educational problems and work to find strongsolutions to solve them.

• 

  Jumia Egypt

  Aug 2018 - Sept 2019

  After Sales Service Specialist

  Monitoring Customer Satisfaction Quality

• 

  ICME (Abbott Distributor)

  Jun 2021 - now

  • Have been dealt with Abbott Divisions (Transfusion, point of care, molecular and Abbott RDx) to be allowed to register according to EDA criteria and needs.• Played a key role in obtaining marketing authorization for a medical device by coordinating and compiling a comprehensive Technical File and successfully navigating the regulatory approval process.• Developed and implemented a streamlined regulatory strategy for a new product launch, resulting in accelerated approval and market entry.• Successfully managed a team of regulatory professionals to ensure timely submission and approval.• Received recognition for outstanding regulatory compliance during an internal audit, contributing to the maintenance of a robust Quality Management System.• Facilitated the successful resolution of a regulatory issue by collaborating with cross-functional teams, regulatory authorities, and external partners, ensuring minimal impact on product availability.• Reviewed and approved labeling and packaging materials to ensure compliance with regulatory standards, including product labeling, instructions for use, and patient information leaflets.• Monitored and analyzed changes in regulations, guidelines, and industry trends to assess potential impact on product in addition to preparing and submitted regulatory documents. Show less •Developed and implemented a training program that increased employees technical and product knowledge.•Provided technical product demos to prospective customers that highlighted the product’s features and capabilities.•Managed product launch timelines and budgets, resulting in successful product launches with minimal delays or cost overruns• Gained in-depth knowledge about the Hemostasis products, their features, how to use them, and how to troubleshoot them by being point of contact for customers and distributors, providing support and assistance as needed. Show less

  • Regulatory Affairs Section Head - (Registration)

    Jun 2022 - now

  • Technical Product Specialist

    Jan 2021 - now

  • Regulatory Affairs Specialist

    Jun 2021 - Jun 2022