Banu Saritas-Yildirim

- Global regulatory lead for oncology products - US FDA regulatory (IDE, SRD, PMA, CDx) - EU IVDD/IVDR regulatory (performance evaluation assessments, notified body notifications) - Regulatory expert in external and internal stakeholder interactions - Company representative to BloodPAC initiatives

-Lead Reviewer in Center for Devices and Radiological Health/Office of In Vitro Diagnostics in FDA -Consulting reviewer to FDA Centers on companion diagnostics device (CDx) use in clinical trials, preINDs, INDs, NDAs, and BLAs for oncology therapeutics -Pre-market and post-market review of medical devices in cancer diagnostics - Reviewer of original submissions, supplements and reports of IDEs, PMAs, presubmissions, 510(k), 513(g), breakthrough device designations - AAMI certified for Quality Systems Regulation - Medical Device Reports specialist/Office representative - Experience in post-market applications including 30-Day Notices, Annual Reports, Recalls, MDRs

Center for Devices and Radiological Health (CDRH) Office of Science and Engineering Labs (OSEL) Division of Biology, Chemistry, and Materials Science (DBCMS) - Performed research to address the post-market safety issue to metal leaching medical devices. - Identified of immune responses to metal ions and nanoparticles that leach from medical devices using flow cytometer and real-time PCR. - Performed research to identify molecular toxicity of metals and nanoparticles to human tissues. - Performed research in personalized medicine to identify diagnostic biomarkers for metal hypersensitivity and allergy using next-generation sequencing. - Expert in bioinformatics analysis of next-generation sequencing data. - Collaboration with National Institute of Standards and Technology (NIST) for establishing next-generation sequencing standards. - Reviewed scientific data in support of research projects, research protocols and funding applications for proposed new scientific testing and methods to evaluate the accuracy and safety of medical device products. - Performed studies to generate Ebola virus-like particles (VLPs) in human cell lines including investigation of Beta-lactamase activity using flow cytometer. - Member of Society of Toxicology (with membership to Metals Specialty Section, Medical Devices and combination Product Specialty Section, Reproductive and Developmental Toxicology Specialty Section)

- Postdoctoral representative in the Executive Committee of the Medical Devices and Combination Products Speciality Section in the Society of Toxicology - Attended monthly Executive Committee meetings - Helped plan the activities for 2019 SOT annual meeting, workshops, and seminars - Helped organize a workshop on Toxicological and Chemical Characterization and Risk Assessment of Medical Devices - Worked closely with toxicologist in FDA and Medical Device Industry

Designed, performed, interpreted experiments to understand the role of F-box dependent protein degradation pathway in nervous system development.

- Research and Development of Microbiology Medical Devices - Produced antigens for rapid detection of Influenza viruses - BD Veritor System for Rapid Detection of Flu A+B - Worked under GMP - Basic Quality Assurance training

- On-field representation of the drugs Prozac and Evista. - Excellent communication skills with physicians, pharmacists, and patients

BS Student in Biology (TOXICOLOGY RESEARCH GROUP) -Senior thesis to study the effects of environmental toxicity on marine vertebrates and the mechanisms of detoxification through cytochrome P450 enzymes.