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Medical Devices, Combination Products, Biotech, Pharma, R&D, Operations, Manufacturing, and Supply Chain
Experienced global leader of R&D, Technical Operations, and Manufacturing organizations. Industrial focus in Medical Devices, Small Molecule Pharmaceuticals, Biotech, Packaging/Labeling, and Combination Products. Broad functional experience in the fields of Project and Personnel Management, Logistics, Supply Chain, and Finance. Successful…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
Medical Devices
Expert has about 10 publications on ablation. He published papers on this area and had grants to develop radio-frequency cardiac and liver ablation systems. He founded and directed a laboratory for medical device testing under IEC standards. Overview of Skills:…
Dental Medical Device Industry
Expert is a marketing and advertising professional with a decade of experience in the cosmetics and dental industries. She is currently a marketing consultant at Bio-Concept Dental Implants (as of 1/2016). Prior, Ms. Expert was a Product Manager for the…
Intellectual Property, Patents, and Medical Devices
Expert is an award-winning, Oxford-educated scientist with expertise in electronics, medical imaging, medical devices, sensors, semiconductors, MEMS, image processing, and signal processing. He has been deposed in a patent case. His experience spans a variety of industries and applications, including…
Medical Device Pathology
His areas of expertise include the following: • Inflammation and vascular cell biology/pathology • Medical device, drug delivery, and biomaterials histopathology • All phases of preclinical research • Regulatory, R&D, sales and marketing, and clinical issues He was a founding…
Semiconductors, Electronics, Manufacturing, and Medical Devices
Expert is a hands-on and technical executive with over 12 years' leadership experience building hardware businesses from the ground up. He has done so as a start-up founder or 1st CEO, with successful financing and exits, and as a Business…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
FDA Regulatory Expert Witness Regarding Medical Devices, Drugs, Software and Data Integrity
Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions: 1) What did the…
Food Labeling; Food, Spring/Bottled Water, Drug and Medical Device Good Manufacturing Practices
Expert was a California Food & Drug Investigator for 26 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. She was responsible…