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Randy Quinn
The world is a big place and navigating through complex medical device regulation is a mission to behold. Meet Randy. He works tirelessly to plot our course and ensure SCIEX diagnostic products meet global market needs and regulatory standards.
"I believe Mass Spec represents the next genesis of diagnostic technology, so I’m excited to support SCIEX Diagnostics in this effort."
Overview
Randy is a Principal Regulatory Affairs Specialist. As part of the Regulatory Affairs Team, he is responsible for ensuring the designs of new products meet the intended global standards and regulations. Outside of the office, he enjoys painting, woodworking, working on cars, and frequenting yard & estate sales in his old truck with his wife.
How would you describe what you do at SCIEX to your family and friends?
"My daily tasks include supporting new product development i.e. ensuring designs meet intended global regulations and standards, assessing modifications to determine regulatory impact such as to IVD product registrations, and review and approval of marketing materials. When describing what I do to family and friends I tend to brag more about the cutting-edge technology SCIEX provides to researchers, hospitals, and forensic labs rather than explain my roll. Not everyone gets excited about regulatory affairs – I know, hard to believe."
What excites you about your role here at SCIEX?
"I believe Mass Spec represents the next genesis of diagnostic technology, so I’m excited to support SCIEX Diagnostics in this effort."
What are some recent projects you have worked on?
"In 2018, I was part of a Kaizen team which created the new Danaher Guidance entitled ‘Product Claims Creation and Substantiation Guidance Document’. I am currently modifying SCIEX procedures related to the creation, review, approval and dissemination of customer facing materials to ensure they are compliant with this guidance."
What is it about the regulatory role/regulatory process that makes it so imperative to SCIEX’s growth?
"In recent years global medical device registration requirements have changed significantly. Europe, for example, has overhauled their Medical Device/IVD Directives and the FDA has been changing their Pre-market submission processes as well. Countries which in the past were without registration requirements, such as middle eastern countries, now have them. The Regulatory team stays abreast of these changes ensuring SCIEX products are available to meet global market needs."
What are some of the biggest game changers you see in the advancement of your particular job as it relates to SCIEX?
"Managing global registrations for all SCIEX Diagnostics products is a challenge. Each region has unique submission requirements, timelines, license expiration and renewal dates etc. The regulatory team is looking into an application to better track and manage global registrations."
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