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The Role We’re looking for a FDA Regulatory Specialist to join the growing legal team.  In this role, you will be the primary point of contact for in vitro diagnostic (IVD) and specimen collection kit-related matters, including assisting with product development, classification questions, regulatory submissions, if applicable, as well as reviewing label/labeling, advertisement, promotional, and other customer facing materials for compliance with FDA regulations and guidelines. Further, you will be advising on questions related to compliance with laboratory regulations such as CLIA requirements.   You will be part of the dynamic FDA practice where you will be a key partn