Plamena Entcheva-Dimitrov, PhD, RAC

San Francisco Bay Area United States

Expert Regulatory | Clinical | Quality Management | Stanford University Lecturer and Mentor | Co-author at AAMI

A results-oriented executive with experience in regulatory affairs, quality management and clinical science and Ph.D. degree in Molecular Microbiology and Genetics, specialized in biofilms. Uniquely experienced and knowledgeable in the areas of both device and drug regulations, clinical research and quality management Regulatory intelligence, strategy and operations experience; hands-on, practical approach. Ability to drive for completion in different areas of regulatory affairs, clinical, QA, and R&D. Types of Submission: Original PMA, IDEs, Amendments and Supplements, Pre-IDEs, 510(k)s, de novo submission, Annual Reports, Technical Files, Pre-INDs, Phase 1 and Phase 2 INDs, NDA. ...