Tracy has been in the biotechnology industry for 18 years with more than 10 years focused on In Vitro Diagnostics (IVDs). She is experienced in manufacturing, quality control (QC)/ quality assurance (QA) and product development for IVDs, with a particular focus on immunoassays and cell-based assays.
Tracy joined NAMSA in 2021. Prior to joining NAMSA, she worked at ImmunoChemistry Technologies for more than a decade in various roles, most recently as Director of R&D and QC, where she managed product development and commercialization for a large portfolio.
Tracy holds a BSc in cell biology from the University of Minnesota, Duluth.
- Project management and cross-functional leadership for the clinical, regulatory and reimbursement teams ensuring accurate and timeline project completion
- Proposal development and quoting of NAMSA support, as well as ensuring accuracy and timely delivery of proposals to customers
- Experienced in IVD assay and product development in areas such as immunoassays and cell-based assays
- IVDR Technical File Support for 14 Hematology Products
- Gap assessments, literature searches and full Technical File development for 14 devices to help sponsor prepare to obtain regulatory compliance with the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on IVD medical devices (EU-IVDR 2017/746) for devices with a current CE Certificate on their systems and reagents
- COVID-19 EUA Point-of-Care Clinical Study
- EUA clinical study support for Rapid Molecular COVID-19 test in a Point-of-Care/Clinical Laboratory Improvement Amendments (CLIA)-waived setting—support included protocol, site support (identification, qualification, contract/budget negotiation, initiation and subject Informed Consent Form [ICF] verification), statistics, data management and clinical study report writing
- Reimbursement Consulting for Whole Blood Point-of-Care Coagulation Assay
- Broad-scope reimbursement consulting, including the following reports and presentations: Reimbursement Landscape, Payer Perspective Analysis, Private Payer Research and Qualitative Claims Map