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,...

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...

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.

Energy and Power Plant Expert for Combustion Turbine Plants, Nuclear Plants, Petrochemical Power Plants, Coal Plants, and Boiler Islands.Environmental project and permitting management for electrical power plants.Design, construction, and startup or electric and petrochemical power plants.Combined cycle project development.Integrated gasification technology development.Clean air act and multi-pollutant compliance project implementation.Power plant betterment/life extension project implementation.Chemical plant/power plant startup and commissioning.

Aerosol Expert for Performance Studies and Regulatory Agency Compliance, Including Quality Assurance of OTC Drug Products.Aerosol issues (troubleshooting, clogs, leaks, failures) and aerosol performance studies.Quality assurance, control and regulatory with experience in manufacturing OTC drug products.Communication and compliance with FDA, EPA, CARB.Developing new systems capable of tracking location and status of all components, raw materials, and finished goods while product is in operation.Undisclosed Company, Quali...

Medical Device Consultant (In-Vitro Diagnostics - ISO 13485, 510k, De Novo, CE, CFR 820) with International Experience in Consulting, Program/Project Management, and Manufacturing510k submissions in medical devices.New business and PMP skills managing multiple international projects.Technical proficiencies and strategic planning to optimize existing products and develop new IVD assays.Risk management: Providing risk management assessments, FMEA - design and process, and developing risk management protocols.Composing and documenting product requirements specific to FDA, CLSI, ISO and CE regulations.Technology transfer.Regulatory activities...

Occupational and Industrial Toxicology Expert: Program Development, R&D and Product Safety Working in the Biotechnology, Medical Device and Pharmaceutical IndustriesOccupational and industrial toxicology, development programs (both preclinical and clinical) and study design.Conduct and reporting, in evaluating clinical and product safety data, in training and managing staff; in dealing with a wide range of U.S. and foreign regulatory bodies.Addressing commercial concerns, and contract research organizations in labeling and other FDA compliance issues for drugs, devices and dietary supplements.Identifying, developing and implementing new...

Recombinant DNA E. Coli Fermentation Development Expert Specializing In Fermentation, Scale-Up, Technical Transfer and ValidationDevelopment of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Scale up of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Technical transfer of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.Validation of GMP E. coli, yeast, and actenomycete, fermentations for pharmaceutical production.

Fermentation Expert in Compliance Activities, FDA API Manufacturing (US and European sites) Commercialization, FSMA PCQ1 trainer, Development of Procedures Laboratory Methodology and TrainingRegulatory support for organizations dealing with new product approvals and introduction, expanding operations, technology transfer, and changing customer, regulatory or certification requirements.FSMA (Food Safety Modernization Act) compliance in regulatory analysis, strategies and meeting deadlines.FSPCA Lead Instructor (Human Foods Certified and Animal Foods Certified), providing PCQI training to industry and regulatory agencies, including FDA.Preve...

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...