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Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Construction Safety
Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…
Hospital Administration, Health Care Administration, Patient Safety, Labor Relations, Physician Mgmt., Physician Credentialing
Expert has successfully served as President and CEO of hospitals and health systems for over 25 years. These organizations include for-profit and non-profit hospitals, urban, suburban and rural facilities, teaching hospitals, trauma centers, acute and sub-acute (LTAC, Rehab, SNF, Home…
Health Physics, Radiation Safety and Measurements, Nuclear Waste, Nuclear Power, Decommisionng
Expert is an independent nuclear power consultant in Sweden serving the Swedish and international nuclear power companies with expertise in radiation and nuclear safety related tasks. He was the head of the Radiochemistry Department in Ringhals Nuclear Power Plant and…
Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment
Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials design and management, community-based research, educational programs’ development and…
Pathogen Detection, Rapid Methods, Food Preservation, Antimicrobial Effectiveness Testing, Herbs
Expert has extensive experience (20+years) in food microbiology research including molecular pathogen detection methods and antimicrobial effectiveness testing. She has provided technical leadership and contributed expertise to develop and evaluate DNA-based methods and immunoassays for detection of pathogens including E.…
Heterogeneous Catalytic Hydrogenation for the Production of Fine Chemicals
Expert has applied his organic chemistry/heterogeneous catalysis/reaction engineering background to the development of processes for the production of pharmaceuticals, vitamins and nutraceuticals, agrochemicals, flavors and fragrances, liquid crystals and fine chemicals as well as base chemicals. He has broad experience…
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…
Near Infrared Spectroscopy, Multivariate Analysis, Pharmaceutical Analysis, (GMP)
Expert is an internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods, including near-infrared and multivariate analysis. Nineteen years of industry experience with increasing responsibility and five years of policy…
Medical Device Technology, Molecular Biology, Virology, Infectious Diseases, Tissue Engineering
Expert is a Clinical Trials manager in the National Health Service, UK; where she is involved in Stroke trials. She has had significant experience in the area of Tissue engineering and Stem cell biology for the last 5 1/2 years…