Umna Razi
Regulatory Affairs & Quality Associate at Surgmed Group- Claim this Profile
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English Full professional proficiency
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Experience
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Surgmed Group
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Canada
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Medical Equipment Manufacturing
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1 - 100 Employee
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Regulatory Affairs & Quality Associate
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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.
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Nexelis, a Q² Solutions Company
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Canada
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Pharmaceutical Manufacturing
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200 - 300 Employee
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Regulatory Affairs Associate
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Apr 2021 - Mar 2022
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Activa Clinics (Wellness)
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Canada
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Wellness and Fitness Services
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1 - 100 Employee
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Medical Report editor
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Sep 2018 - Feb 2019
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Education
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University of Toronto
Bachelor of Applied Science - BASc, Microbiological Sciences and Immunology -
Humber College
Associate's degree, Biotechnology