Cepheid
Kimberley Low is a skilled professional in regulatory affairs with extensive experience in managing regulatory databases and compliance processes within the medical device industry. Currently serving as a Senior Regulatory Affairs Process Specialist at Cepheid, Kimberley oversees multiple regulatory databases and leads continuous improvement projects, including the formal validation of TrackWise Software. Previously at Dexcom, Kimberley played a pivotal role in designing a new Regulatory Affairs Database and was involved in international regulatory compliance efforts. Additional roles at Dexcom included coordinating regulatory submissions and supervising a team focused on customer advocacy. Kimberley also gained valuable laboratory experience through various assistant roles at UCSD, further strengthening a background in microbiology earned from a Bachelor's degree at the institution.
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Cepheid
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Cepheid is a molecular diagnostics company. The Company develops, manufactures and markets fully-integrated systems for testing in the Clinical and Non-Clinical markets. The Company's systems enable molecular testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The Company's systems integrate these steps and analyze biological samples in test cartridges. Its primary offering is the GeneXpert system, which integrates sample preparation in addition to Deoxyribonucleic acid (DNA) amplification and detection. The GeneXpert system is designed for a range of user types ranging from reference laboratories and hospital central laboratories to satellite testing locations, such as emergency departments and intensive care units within hospitals, as well as physician offices and other alternate site laboratories. It also offers the SmartCycler system, which integrates DNA amplification and detection to allow rapid analysis of a sample.