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Tina Higgins, PhD, currently holds roles as Senior Advisor at BioChip Labs and in Regulatory Affairs and Quality Systems at XaTek (ClotChip) since May 2023, while also serving as the Owner of Higgins McNamara Consulting since April 2021. With extensive experience in regulatory submissions and quality systems for medical device companies, Tina previously worked as Vice President of Clinical Operations and Regulatory Affairs at LightDeck Diagnostics, leading clinical and regulatory initiatives for IVD products. Additional roles include Interim Executive Director of the Sickle Cell Disease Regulatory Science Consortium at Critical Path Institute and Vice President of Clinical Diagnostics at OPKO Diagnostics, where Tina contributed to multiple successful regulatory submissions and clinical study designs. A PhD graduate in Biomedical Sciences from Cornell University, Tina has a robust background in diagnostic development and regulatory strategy, stemming from earlier positions at ECI Biotech, NovaSterilis, and academic research at Cornell Medical College and Worcester Polytechnic Institute.