Tina Higgins
Regulatory Affairs and Quality Systems @Xatek Clotchip
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WORK HISTORY
Regulatory Affairs and Quality Systems @Xatek Clotchip
EDUCATION
Worcester Polytechnic Institute
B.S.
Cornell University
Ph.D.
ABOUT TINA HIGGINS
Experienced leader of In Vitro Diagnostics development and clinical validation activities under ISO13485/MDSAP, with a Ph.D. in Biomedical Sciences and 10+ years’ experience bringing IVDs through FDA approval (PMA, 510(k), De Novo, and Laboratory Developed Test) and CE marking. • Effective communication and collaboration skills that have guided internal and external stakeholders to build compliant and efficient product development processes for success with regulatory agencies. • Incorporate strong scientific and technical background to partner in QA/RA tasks with technical teams, finding efficient and robust solutions to achieve compliance • Contributor to industry standards development and professor of practice in IVD development and regulation.
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