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Ashleigh C. Dawley, RAC

Director, Regulatory Affairs and Compliance
Integrated DNA Technologies, Inc., a Danaher Company, United States

Specializing in in vitro diagnostic (IVD), companion diagnostic (CDx), and high risk medical devices, Ashleigh has almost a decade of experience working in both industry and as a consultant on a number of novel technologies. Joining IDT in 2021, Ashleigh oversees the regulatory, design quality assurance and various product compliance functions of IDTs unique portfolio which encompasses RUO products, including a number of novel software tools, contract manufacturing services offered under IDTs certified quality management systems and build out of cGMP manufacturing services to support the genomics medicine industry.

Regulatory knowledge and expertise spans the complete product lifecycle including R&D, study design (analytical and clinical), quality control, regulatory strategy of complex products through global submission preparation/approval, as well as marketing and commercialization strategies from a regulatory perspective with proven results in both market access and clinical trials in 60+ countries.

Disclosure information not submitted.

Presentation(s):