Umna Razi

Regulatory Affairs & Quality Associate at Surgmed Group
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Contact Information
Location
Montréal-Ouest, Quebec, Canada, CA
Languages
  • English Full professional proficiency

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Experience

    • Canada
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs & Quality Associate
      • Mar 2022 - Present

      • Executed the review and update of the industry guidance document for mandatory adverse reaction reporting • Completed ad-hoc projects such as creation of standard operating procedures (SOPs), performing searches and updating internal documents• Researched and interpreted regulatory information pertaining to health product AR and medical device problem reporting legislation• Monitored, tracked and maintained a list of incoming and outgoing inquiries received from industry, hospitals, public and other bureaux within the organization.• Participated in issues management/ projects related to quality management systems.• Led interactions from first-submission to submission cycle of medical devices with Health Canada, FDA, and other regulatory bodies.

    • Canada
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Regulatory Affairs Associate
      • Apr 2021 - Mar 2022

    • Canada
    • Wellness and Fitness Services
    • 1 - 100 Employee
    • Medical Report editor
      • Sep 2018 - Feb 2019

Education

  • University of Toronto
    Bachelor of Applied Science - BASc, Microbiological Sciences and Immunology
    2016 - 2019
  • Humber College
    Associate's degree, Biotechnology
    2020 - 2021

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