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Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Environmental Services, Regulatory Compliance, Waste Transportation & Disposal, Landfills
20+ Years Environmental Management Experience / Leader in Business Strategy & Acquisition / Western US Facilities Oversight / Training & Regulatory Compliance / Human Resource Management & Professional Growth Expert is a results-driven business professional with 20+ years’ experience in…
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…
Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Mechanical Engineering, New Product Design and Development, Fluid Systems, Electronics Packaging
Expert has been in business developing new products since 1985, specializing in instrumentation, medical and laboratory equipment. Besides electronics, some other areas of expertise include: mechanical components and systems, plastics, pneumatic and fluid systems, thermal design and analysis, packaging of…
Web Coating Technology
Expert has spent over 28 years in the web coating industry. He has experience in wax coating, hot melt, solvent coating, solventless coating, and emulsion coating on a wide variety of webs, from light weight films and foils to SBS…
Immunology, Vaccine Research
Expert is an internationally recognized expert in mucosal immunology. He has published more than 70 papers and reviews in several prestigious scientific journals. He is best known for experimentally establishing (with continuing research) the concept of a common mucosal immunologic…
Stormwater Management, Environmental Spill Containment and Response, Radwaste Packaging and Filters
Since 1981, Expert has been involved in understanding, interpreting, and keeping up-to-date with DOT packaging standards, specifically the Hazardous Materials Transportation Regulation for containers and non-bulk packaging. He has worked closely with the exemptions branch, and has applied for and…
Automated Chemical Sensors
LABORATORY COMPUTERIZED ANALYTICAL INSTRUMENTATION DESIGN; CHEMICAL AUTOANALYSIS. Expert has spent much of his career developing systems or subsystems for devices accomplishing automated chemical analysis. He has experience in all phases of this process, from basic research into sensors to the…
Uses of Polymers, plastics, silver and other metals. EPA regulatory processes
For the past 25 years, expert has been actively involved in all phases of medical plastics synthesis, processing, and use. His experience includes custom formulation of polymers, analysis of medical markets, and selection of materials that will withstand the various…