Principal Consultant
Qserve Group
Christie Hughes, MPH, MLS(ASCP), RCC-IVDR is a Principal Consultant and IVD Expert with Qserve Group who has over 25 years of experience in the in vitro diagnostic medical device (IVD) industry. With a degree in medical laboratory science, she began her career in hospital clinical laboratories. Upon moving into industry, Christie worked in various quality and compliance roles at small and startup companies where she established their quality management systems (QMS) compliant with ISO 9001, ISO 13485, and FDA QSR requirements. To learn other aspects of the industry, Christie led commercial and post-launch phases for a molecular test as a Product Manager before moving into Regulatory Affairs where she developed and executed domestic and international regulatory strategies for IVD instruments, software, and multiplexed assays (protein and molecular). After many years in various roles in industry and earning her master’s in public health degree in epidemiology, Christie moved into consulting where she continues to leverage her experience and knowledge to determine elegant solutions for clients’ QMS and regulatory affairs challenges. Christie’s expertise includes regulatory strategy, regulatory submissions, design controls, risk management, QMS implementation, and conducting audits with a focus on compliance with regulations covering the United States (FDA) and Europe (EU IVDR). Her most recent work involves assisting clients with navigating IVDR requirements for clinical performance study authorization, transitioning technical documentation for legacy IVD devices, and assessing QMS documentation for compliance as well as providing global regulatory strategies and assisting clients with FDA Q-Sub pre-submissions. Christie is also one of the first regulatory professionals to obtain RAP's regulatory compliance certification specializing in the IVDR (RCC-IVDR).
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Wednesday, May 8, 2024
10:25 – 11:25 CEST