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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…
Competitive Intelligence from Primary Sources in Pharmaceuticals, Diagnostics, and Medical Devices.
•Business research and development professional with a successful record targeting and developing Fortune 500 clients. •Founded pharmaceutical and information technology business intelligence firm and served as Business Development & Research Director for 15 years. •Expertise assessing the unique challenges facing…
Flexible Packaging Materials; Film Extrusion, Extrusion Lamination, Food Packaging, and Food Packaging Safety
Fellow, Society of Plastics Engineers Inductee, Packaging Hall of Fame Expert has spent over 35 years in the development and application of functional materials for a variety of packaging and non-packaging applications (process and platforms). He has developed various multi-layered…
Knowledge Management, Facilitation, Change Management, Organizational Strrategy and Performance, Federal Acquisition and Procurement
Developed and embedded corporate-wide practices for the explicit management of organizational and client knowledge into the business and operational processes of the company making collaboration and knowledge sharing in and across our teams a routine part of planning and operations.…
Energy, Utilities and Engineering Based Businesses: Strategy, Operations & Systems; Energy Markets
Expert is a consultant and management expert in the utilities, energy, engineering and automation sectors. He has managed large national and international organizations (utilities, energy service and engineering companies and divisions) in Europe and Asia and has developed and delivered…
Polymer Allloys and Blends, Plastics Additives, Impact Modifiers, PVC Formulation/Processing
Expert has the expertise and fundamental training in polymers, especially in polymer alloys, where he holds a Ph.D. in Chemical Engineering with an emphasis in polymer science. During the course of his career, he first entered academia, becoming a full…
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…
Process/Materials Development and Optimization in the Pulp, Paper and Nonwovens Industries
Expert has 30 years experience producing fibers and structures designed to yield optimal absorbent performance on a variety of substrates (water, oils, urine, menses, etc.). Expert's structures have been adapted and implemented in numerous consumer and B2B products currently on…
Chemical Process and Catalyst Technologies, Licensing, R&D, Engineering, General Management
Expert spent his industrial career first as a process and catalyst development engineer, and ending up as the president of two organizations, each involved in developing and licensing chemical processes and developing and selling heterogeneous catalysts to the global chemical…