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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…
Hazardous Materials, Retrospective Toxic Chemical Exposure Assessment, Mold, Hazard Communication
Results oriented environmental scientist with over 35 years of experience providing consultation and litigation support in the fields of, industrial hygiene, retrospective toxic exposure assessment, indoor air quality, indoor mold contamination, hazardous consumer and industrial products, chemical hazard communication, labeling…
FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media
Expert currently serves as Regulatory Counsel for Allergan, providing proactive legal support to senior management, product brand teams, and client groups across organization, advising and educating on regulations pertaining to pharmaceutical products. He serves on multiple brand advertising and promotional…
Confined Space Entry Fatality Investigations, Occupational and Industrial Hygiene
* Expert is a court recognized Expert Witness in Confined Space Entry and has testified in court cases in the United States and Canada. * Lead Investigator for both a Regulatory Authority and industry in a number of confined space…
Occupational Safety and Health, Hazard Recognition/Abatement, Citation Resolution, OSHA/MIOSHA,
Expert is currently the Director of an safety consultanting firm and is providing safety and health services which include audits/surveys with a written description of hazards and safety/health training on the specific hazards found in the work place. He has…
Personal Care Cosmetics, Skin & Underam Care-Formulation Development-Application-Claim Support, INC Regulations, Ingredients, Formulation, Expert Witness
Besides working as Senior Principle Scientist for Kao Brands (Curel Technical Brand Mgr, Jergens Technical Leader, Ban AP innovation, John Frieda Innovation), Expert has worked for Dow Corning as a Senior Technical Service Scientist in the field of silicone chemistry,…
HACCP, LACF, Low Acid Aseptic, Process Controls, Process Improvement, System Design, Value Added, Resource Allocation
Expert is a consultant to the Food Manufacturing and Process Industry utilizing excellent interpersonal skills and an aggressive hands on approach. He has successfully liaised with clients and staff, identifying and correcting for food and ingredient manufacturing issues proactively as…
Clinical Pharmacology, Toxicology, Drug Development, Product Liability, Regulatory Affairs, Pharmaceutical Patents
Expert worked in pharmacological research concerning opiate analgesics. The objective of the research was to find an anti-diarrheal drug with minimal analgesic and addiction potential. In particular, he led the research team that discovered and developed nufenoxole, an antidiarrheal drug.…
Customs, Imports; Trade Policy & Compliance; Global Trade Strategy; Finance; International Business
Expert has created and implemented many international trade compliance, training and self-assessment programs. Her experience covers a broad range of industries (medical and health care, food and agriculture, consumer electronics, automotive, etc.) for various Fortune 500 companies, among others. She…