Marganne Miller
Regulatory Affairs Specialist II at Epredia- Claim this Profile
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Bio
Credentials
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ISO 13485:2016 Lead Auditor (TPECS)
BSIJul, 2019- Nov, 2024 -
Leading Management Systems Audit Teams (ISO 19011:2018)
BSIJul, 2019- Nov, 2024 -
Medical Devices Quality Management Systems ISO 13485:2016
BSIJul, 2019- Nov, 2024 -
Histotechnician, HT (ASCP)
National Society of HistotechnologyJan, 1995- Nov, 2024
Experience
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Epredia
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United States
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Biotechnology Research
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500 - 600 Employee
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Regulatory Affairs Specialist II
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Mar 2017 - Present
Managed regulatory function of IVD medical device manufacturing site for anatomical pathology consumables focusing on premarket (technical file development, regulatory strategy) and postmarket activities (recalls, promotional material review) , new product development, domestic and international registration and general site activities according to ISO 13485. Managed regulatory function of IVD medical device manufacturing site for anatomical pathology consumables focusing on premarket (technical file development, regulatory strategy) and postmarket activities (recalls, promotional material review) , new product development, domestic and international registration and general site activities according to ISO 13485.
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Thermo Fisher Scientific
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United States
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Biotechnology Research
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700 & Above Employee
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Laboratory Applications Specialist
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Jan 2009 - Mar 2017
Increased customer satisfaction by providing technical troubleshooting of consumable and instrument product portfolio through call-in center support, on-site customer training classes, V&V testing and participation on new product development core teams across the APD division as well as supporting Sales, Marketing and R&D activities.
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Quality Assurance Histotechnologist
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Jan 2008 - Jan 2009
Focused on business development by successfully integrating new product portfolio from company acquisition into laboratory quality program by developing quality testing specifications and stability program. Investigated customer complaints with trending and lead PPI teams for process improvement. Promoted safety and awareness through membership on the site Safety Committee and First Responder team.
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Product Specialist Tech-Rite
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Jul 2007 - Jan 2008
Enhanced customer experience through technical troubleshooting, cross-referencing and complaint handling. Developed, implemented and performed consumable and instrument product training classes.
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Richard-Allan Scientific
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Medical Equipment Manufacturing
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1 - 100 Employee
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Instrumentation Technical Consultant
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Mar 2005 - May 2007
Increased customer safety and satisfaction by performing quality checks on new, customer and demo instruments. Worked within the Service department to troubleshoot instruments and dispatch service personnel to customer site.
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Tech-Rite Consultant / R&D Technician
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Mar 2001 - Mar 2005
Enhanced customer experience by supporting Sales & Marketing with in-depth instrument and consumable troubleshooting via phone and on-site visit. Served as technical expert at trade shows and customer facing events. Developed and performed slide matching program to increase product sales. Performed various R&D activities as well as complaint investigation.
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Quality Assurance Histologic Specialist
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Sep 1998 - Mar 2001
Hired as resident histotechnician to complete performance analysis of manufactured consumable products and support complaint handling. Identified process improvements in batching and the laboratory and cross-trained on the chemist role. Created QC evaluation criteria and performed functional testing for new instrumentation acquisition.
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Education
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1987 - 1991
Aquinas College - Grand Rapids
Bachelor's degree, English and Environmental Studies
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