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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…
Security System Design, Vulnerability & Threat Analysis, Critical National Infrastructure Protection
Expert is one of three directors who form a specialist security technology consultancy practice with in-depth and wide-ranging experience in designing and deploying security technology solutions. His consultancy provides effective technical advice based on the understanding of security threats, the…
Systems Engineering, Project Management, Programme Management, Software Development
Expert has applied his systems engineering expertise in a wide range of information systems in the aerospace, defence and transportation sectors. He has developed and deployed innovative systems engineering processes and used these on many of the projects and systems…
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…
Industrial Design, Product Design, Manufacturing and Engineering
Expert has over 15 years professional experience in Industrial, Product Design and Engineering, having worked with clients such as Selfridges, Bell Helmets, Giro Sport Design, and Dow Corning. He has a detailed knowledge of the design process from conception through…
Phased Array Radar Systems, Antenna, Microwave, Guidance and Control Systems
Expert has more than 20 years with defense industry (Lockheed Martin, and Raytheon). He is a Radar System Expert and Analyst of Radar System performance and Phased Array Radar Systems for more than 15 years (recently designed EQ-36 mortar radar,…
Medical Device Software, Safety Critical Systems, Embedded Systems Design
Expert managed the Electrical Engineering department of a consulting company specializing in medical device design. He has designed software, firmware and hardware for medical devices including a Proton Beam Radiotherapy system, blood infusion pumps, blood analyzers, hysterscopic pump, drug scanning…
Rapid Development of Controlled Release Drug and Drug-Device Combination Products
Expert, Ph.D., is an independent consultant with 15+ years experience in developing controlled release implantable and injectable products for proteins/peptides and small molecule drugs, spanning from chronic/systemic delivery to acute/local delivery, with special focus on drug delivery platforms and drug-device…
Chartered Engineer Mechanical/Aerospace CPEng,RPEQ,Aircraft Valuer,Aircraft Structures,Management
Honored with Fellow of Royal Aeronautical Society,London award for outstanding contribution to Aerospace Industry. A Professional Aeronautical Engineer with wide background experience backed by appropriate qualifications as listed and Recipient of First Ever Royal Aeronautical Society Cayley Award, awarded by…