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.

Broad Based Health Care Regulatory Consultant: Operational Excellence, IT, Product Portfolio Management, Health Care Product Portfolio Management and Quality System ConsultantOver 16 years in the pharmaceutical, medical device, biotechnology and healthcare industries.Subject matter expert in health care product portfolio management, project management, operational excellence, quality system improvements, system development life cycle (SDLC), computer system validation (CSV) and regulatory compliance in global operations.Assessments of business operations, quality assurance programs, regulatory, compliance, information technology and manufa...

Polypropylene Technical and Marketing Expert in consumer, medical and industrial polyolefin marketsSenior Plastics Consultant with a marketing and finance MBA.Extensive new business and application development of polyolefins, bringing 28 years of experience.Created a technical team for a grassroots polypropylene plant.In depth understanding of polyolefin products, processes and applications.Detailed knowledge of the consumer, medical and industrial polyolefin markets.Technical and marketing support to Asia, South America and Africa for over seven years.Merger and acquisition evaluations.

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...

Medical Device Consultant with Broad Experience in Business Management, R&D, and Regulatory Compliance: FDA, ISO, CEMedical device product development, market positioning, strategic planning, and branding strategy.Regulatory affairs and compliance, (FDA, ISO and CE approval processes).Technology leader providing equivalent support for the health care, security, intellectual property, and space industries while successfully developing new businesses in the U.S. and abroad.Budget and resource management, contract management and negotiation, change management and restructuring, profit and loss accountability, forecasting and trend analysis,...

Medical Device Consultant Specializing in Materials, Design, Test Method Development, Product Development, Quality System Regulations, Process Validation, Supplier Qualification, ISO, FDA and REACH Compliance. Medical Device Process Validation Consultant, Supplier Qualification, ISO, FDA and REACH compliance.Product development from concept to market.21CFR820 (cGMP) and ISO13485 QSR.Polymers and materials for medical devices.Vascular and catheter systems.DOEs and process optimization.Process Validation (IQ, OQ, PQ).Medical device design control process.EPA, FDA, REACH and RoHS compliance regulations.Fluoropolymer and lubricious coating com...

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...

PhD Biostatistician with expertise in Regulatory (FAD and EMA activity), Data - Safety Monitoring in the Pharmaceutical and Medical Device Industries. Scientific Advisory Participant.Biotechnology FDA and EMA submission in the pharmaceutical and medical device industries.Biostatical litigation specific to pharmaceutical and medical devices.Pre- and Nonclinical, Phases I - IV in biostatistics, data management, statistical programming, and etechnology across various therapeutic areas.Analysis of over 420 clinical studies, with over 30 in Integrated Summary of Safety and Integrated Summary of Efficacy (ISS/ISE).Build effective innovative an...

Quality Systems Consultant with Expertise in Vendor Evaluation, Process Improvements, Cost-Non-Quality for Investigations-Various Industries; Healthcare, Security Technologies, Medical Devices, Oil-Gas-Mining Fabrication, Grain Systems, and Specialty MetalsProcess audit specialist; product audit and Quality Management Systems (QMS).Lead 3rd party ISO Audit.Advanced Product Quality Planning (APQP), Production Part Approval Process, PPAP and National Provider Identifier, (NPI) management.Process improvement, value steam mapping and Lean Six Sigma.CAPA, (Corrective And Preventative Action) engineering studies, Statistical Process Control (SP...

Ph.D Scientist with Expertise in MRI Imaging, Pharmaceutical Biomarkers, In-Vivo Imaging and Medical Device ExpertSummaryDeveloping imaging biomarkers for the pharmaceutical and medical device industries.Biomedical imaging and computer sciences.Magnetic Resonance Imaging (MRI) data acquisition and data analysis, image and signal processing techniques, numerical methods, multicompartmental models and linear systems.Development and validation of quantitative imaging (MRI) biomarkers.Project management and study design of scientific (R&D) projects.Site training and implementation of in-vivo imaging studies.Quality control and analysis of imag...