Regulatory Specialist (IVD/CLIA)

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.