Christa is a Director in the Clinical and Medical Affairs department who oversees 100+ Medical Writing Managers, Writers, Information Specialists, Librarians, and Programmers for Johnson & Johnson across all Medical Devices companies supporting both US FDA and EU MDR Post-Market Surveillance requirements and activities (CERs, PSURs, SSCPs, PMCFs ,IDEs, PMAs) for a wide scope of therapeutic areas including cardiovascular, GI, cell therapy, women’s health, general surgery, and orthopedics. Her team owns published literature and associated software tools for systematic reviews and meta-analyses. She comes with 20 years in multiple leadership roles as an epidemiologist, clinical researcher, biostatistician and data manager with expert knowledge in research protocols, data collection instruments, database design, analytic plans, clinical summaries, and biostatistics. She also led the SME during EU MDR audits on PMS requirements specifically around systematic review methodologies to justify the safety and performance of medical devices. She has developed a global training program for medical writers and other multifunctional teams across the medical device sector on clinical evaluations and systematic literature reviews.