Marie Burns
Regulatory Affairs Specialist at Occlutech- Claim this Profile
Contact Information
us****@****om
(386) 825-5501
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Location
Louisville, Kentucky, United States, US
Languages
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English -
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Experience
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Occlutech
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Sweden
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Medical Equipment Manufacturing
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100 - 200 Employee
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Regulatory Affairs Specialist
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Aug 2022 - Present
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Meridian Bioscience Inc.
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United States
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Medical Equipment Manufacturing
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400 - 500 Employee
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Regulatory Affairs Specialist, Post Market and Risk Management
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Jan 2020 - Aug 2022
Label review, UDI Implementation, DHF auditing, FMEA, risk analysis, QMS, IVDR Label review, UDI Implementation, DHF auditing, FMEA, risk analysis, QMS, IVDR
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Eurotrol
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Netherlands
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Medical Equipment Manufacturing
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1 - 100 Employee
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Product Specialist
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Jan 2019 - Jan 2020
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Master's Project
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University of Louisville
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Prototype Microfluidic Systems for Cell Processing
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May 2018 - Aug 2018
Developed and assembled a compact, cost-effective prototype that allows for easy experimentation of cell processing. Integrated ultrasound transducers, microfluidic device, Arduino controller, and 3D printed case. Developed and assembled a compact, cost-effective prototype that allows for easy experimentation of cell processing. Integrated ultrasound transducers, microfluidic device, Arduino controller, and 3D printed case.
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Cook Medical
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United States
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Medical Equipment Manufacturing
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700 & Above Employee
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Engineering Coop
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Jan 2018 - May 2018
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Freudenberg Medical
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United States
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Medical Equipment Manufacturing
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300 - 400 Employee
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Product Development Co-op
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May 2017 - Aug 2017
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Freudenberg Medical
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United States
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Medical Equipment Manufacturing
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300 - 400 Employee
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Product Development Co-op
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Aug 2016 - Dec 2016
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Education
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Beechwood High School
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University of Louisville
2018, Bioengineering and Biomedical Engineering -
University of Louisville
Masters of Engineering, Bioengineering and Biomedical Engineering
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