Haja is an in vitro diagnostics (IVD) veteran, with over 20 years of experience in diagnostic virology, molecular biology, serology, and IVD device development. She dedicated more than a decade of her career within the FDA, in positions of increasing responsibility and oversight, working in both pre- and postmarket medical device regulation, as well as with the FDA’s Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and representing the agency nationally and internationally in developing guidelines and standard documents for the development of IVDs. As an independent consultant, Haja supported numerous IVD regulatory strategies and generated many IVD pre-submissions, 510(k)s, PMAs, pre-EUAs, EUAs, de novos, CLIA waiver applications, IDEs, and BLA applications. Haja possesses extensive knowledge of FDA regulations and policies, providing creative and effective solutions to clients seeking support commercializing IVDs.
At Veranex, Haja manages IVD clients, supporting regulatory requirements for product development, manufacturing, clinical trials, regulatory submissions, commercialization activities, and postmarket compliance. Haja is responsible for formal and informal communications with the FDA as well as international regulatory agencies. Haja’s primary functions at Veranex include:
- Developing thoughtful U.S. and international IVD regulatory/clinical strategies
- Serving as the regulatory representative on client companies’ design teams for IVDs
- Generating pre-submission packages and serving as the FDA client interface for pre-submission meetings
- Preparing U.S. FDA regulatory submissions (e.g., de novos, 510(k)s, PMAs, CLIA waivers, EUAs, IDEs, and HUDs/HDEs)
- Assembling technical documentation for CE marking as well as international registrations
- Reviewing advertising, labeling, promotion, and postmarket compliance activities
- Interfacing with FDA inspectors and notified body auditors
Past companies and experience
Haja began her career teaching at the University of Khartoum, Sudan, before initiating her doctorate research in the Netherlands. Haja’s academic accomplishments led to her first position as a microbiology reviewer at the FDA’s Center for Devices and Radiological Health (CDRH), where she held various roles, including master reviewer and FDA expert in serological and molecular diagnostics of viral infections, Partnership with Patients program manager, and Science Policy Analyst. Haja later joined Biologics Consulting Inc. where she served as a senior IVD consultant to companies seeking support with IVD regulatory strategy and submissions.
Haja received a B.S. in zoology from the University of Khartoum, Sudan, and a MZOOL at Erasmus University. She conducted research on diagnostic methods for the measles virus at the World Health Organization’s (WHO) reference laboratory of virology, which she continued under her diagnostic virology Ph.D. program at Erasmus University Medical Center, in Rotterdam, Netherlands. Haja also holds a Master Certificate in Project Management from George Washington University in Washington, D.C.