I am a Biomedical Engineering professional with excellent leadership, communication, and project management abilities. I have firsthand knowledge of regulatory requirements for BLA, PMA, IND, IDE, 510K, HUD, and HDE submissions and CFR Title 21 requirements for medical devices manufacturing and reporting. In previous positions, I have directed research to support regenerative medicine initiatives for porcine derived small intestine submucosa and human placenta derived tissue, 510K, and BLA products. I have experience working with clinical, quality and regulatory to devise clinical evaluation plans and draft clinical evaluation reports as well as address clinical complaints and link them to appropriate risk documentation per regulatory requirements.I have been working in the medical device and regenerative medicine field since completing my postdoctoral research at Emory University in Tissue Engineering in 2007. In my career, I have managed multiple projects for Class II and Class III devices and tissue based biotherapeutics following CFR Title 21 and ISO 13485 guidelines for medical device design, development and production and ISO 14971 for the application of risk management for medical devices. I am PMP certified by PMI, and I have firsthand knowledge of regulatory requirements for BLA, PMA, IND, IDE, 510K, HUD, and HDE submissions and CFR Title 21 requirements for medical devices manufacturing and reporting. In addition, I have managed the Implementation of potency, purity, and identity assays for CMC requirements for BLA indications, the execution of pharmacokinetics, pharmacodynamics, and safety studies to support preclinical evaluation as well as development of bench, cell-based, and preclinical studies to identify molecular mechanisms for efficacy of amnion derived biotherapeutics.Specialties: Project Management, Design Control, Tissue Engineering, Preclinical Studies, Biocompatibility, Toxicology, Histology, Design Verification/Validation, Grant Writing
Listed skills include Tissue Engineering, Histology, Medical Devices, Glp, and 19 others.
