Providing Diagnostics in Blood Collection Platforms, Develop Control Sensors and Instrumentation for the Pulp & Paper, Plastics Industries, Commercializing New Infrared & X-ray Sensor Technology. Accomplished senior research and development leader, Ph.D. in physics, executing extensive experience in new product development, and focus in optical and medical devices and diagnostics. Targeting customer needs, assessing new technologies, and developing innovative business and technology opportunities. With both Fortune 500 and entrepreneurial, and startup company experience, bringing dynamic leadership and technical expertise to instrume...

OTD/Occupational Therapy and Psychiatric Industry Writing and Author, including the Legal SectorRegulatory Medical Writing Clinical Medical Writing Editing Quality Control Business Development Expert Witness Experience Writing Experience (Phases 1, 2, 3, and 4): Wrote and edited ICH-compliant documents, including investigator brochures (IBs); Investigational New Drug (IND) applications. Marketing Authorization Application (MAA); informed consent documents (ICF); protocols and amendments. Clinical trial agreements (CTAs); clinical study reports (CSRs). Clinical evaluation reports (CERs); biologics license applications (BLA);...

Ph.D. Inorganic Chemist Specializing in Electrochemistry, with Development Expertise for In Vitro Biosensor Technology Sector of Medical DiagnosticsElectrochemistry medical diagnostics.Electrochemical detection technology.Development know how in in vitro diagnostics including electrochemical sensors and biosensors.Chemical sensor technology for Homeland Security Applications.Developing medical and scientific products from concept-to-market.Independent Contractor, PresentUndisclosed Company, Vic...

A Creative Scientist with Proven, Leadership & Business Skills. Extensive Contributions to Top Brands for Fortune 10 Food Companies. Venture Capital Skills in all Phases of Business and Scientific AOrganic Chemist: Trained with deep knowledge and experience in nearly all food systems and technologies. Proficient in food chemistry, thermal analysis, statistical experimental design, polymer chemistry, food microstructure and all food macromolecules. Developed and taught curriculum on water in foods, coating technology, starch and hydrocolloids. Food Product Creator: Baked goods, beverages, teas, snacks, cereals, bars, nutritional supple...

Leading Product Creation Though CE/FDA Submission, ISO, MDSAP Audit, R&D Documents (DHF): DI, DO, Risk, V&V plan, Protocols and Reports. Quality Procedures Implantation, Quality & Regulatory BinderAssurance, Quality Control, and Regulatory Affairs Manage and establish total quality system according to EN ISO 13485:2016, MDD/MDR Requirements and QSR (21 CFR 820). CE ( European Certification) certificated from technical documentation preparation through submission and external audit by notified bodies. Other countries certificates: Japan (including on-site audit), Korea, Canada, Australia, India with special requirements of different...

Consultant for Pre FDA Quality Audits for Medical DevicesMedical Device quality assurance and regulatory compliance professional possessing over 28 years' experience.Manufacturing, pharmaceutical, biologic, and medical device operations.21 years of employment with the FDA, primarily as a Medical Device Investigator.Professional consulting; FDA Medical Device Quality regulations and FDA compliance.ASQ certified, (QBA) medical device regulatory compliance and non-technical quality assurance expert, specializing in medical device quality systems.Failure modes and effects analysis of medical devices.Metallurgical engineering technology as appl...

Medical Device Risk Management, Quality Systems Management, Supplier Qualification and Quality Assurance: In Vitro Diagnostic Medical Devices (Class II), Biotech Manufacturing Operations, Digital Imaging Equipment, and Interventional Devices (Class III), Bio-based MaterialsMedical device and biomedical industry planning, Integration, and organizational improvements, increasing financial performances for U.S. and European businesses.Aligning technology and business strategy, medical device quality management regulations and requirements into effective and useful management systems.Remedial quality management system compliance.Pre-certifica...

Experienced Senior Scientist Obtains Proven Track Record in Research and Product Development, Support, Validation. Clinical Assay Development, Medical Devices, Planning- Executing 510(k) Applications.Summary Experienced Senior Scientist with a proven track record in research and product development/ support/ validation. Clinical Chemistry Expert; polymer chemistry, assay development, medical devices, fluorescence, planning and executing 510(k) studies, writing and editing 510(k) applications. Subject matter expert for chemistry and test method validation on behalf of clients’ companies. Numerous processes validation during compli...

Software Validation and Quality Consultant for FDA ComplianceAuditing for ISO 13485, FDA QSR, ISO 9001, MDD and IVD, CE mark.Specialist on FDA regulated industries and software validation requirments.Process validation, software validation, Part 11, GMP development, ISO 13485 development.FDA response and remedial actions, quality systems creation, quality systems improvement.Creation of technical course and leading training groups on FDA-QSR and Software Quality, including training effectiveness assessments.FDA quality documentation, risk management, specification development and sampling plan analysis and rationale.

Medical Devise Regulatory Consultant with Class II and III Implantable Medical Device Experience: Cardiovascular Grafts, Surgical Mesh, Heart Valves, Periodontal Implants, Sutures and LigamentOver 25 years of experience in medical devices.Experienced in all aspects of medical device product development, including design, laboratory and clinical testing, manufacturing, labeling and quality systems.Extensive experience in medical devices pharmaceutical and in vitro diagnostics industries.Extensive experience with Class II and Class III implantable medical devices for cardiovascular grafts, surgical mesh, heart valves, periodontal implants,...