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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…
ISO 9001, ISO 13485 Aerospace, Medical Devices, Machined and Fabricated Parts, Validations
Expert has written world class mangament systems from scratch including all 4 tiers of documentation. Expert has a track record of supporting flawless registration audits and successfuly implementing systems for small shops and companies that often struggle with such endeavors.…
Medical Device and Product Development Expert
Expert is a seasoned Engineering Leader with over 20 years of experience in Medical Devices, including Product Development and Product Management. He set up the Global Technology Centre for TE Connectivity and Medtronic in India and has established a Catheter…
Operational Excellence & Six Sigma Black Belt
Expert is a Six Sigma Black Belt with over 20 years of experience building infrastructures to achieve operational excellence. He has experience with ERP systems implementation, leadership, strategic planning and organizational development with operational and technical skills. His track record…
Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
Product Development, Mechatronics, Mechanical Engineering, Electromechanical Engineering, Analytical Instrumentation, Machine Design
Expert is an Independent Consultant who advises clients about the Engineering, Design, and Development of complex systems and products. His philosophy is to help clients find the best path for their unique situation. In addition, he is an expert at…
Subsea/Offshore Systems: Design, Manufacture and Commissioning; Fabrication, Mechanical, Electrical, Pneumatic and Hydraulic Applications
The design, manufacture, and commissioning of subsea/offshore systems with vast experience in fabrication, mechanical, electrical, pneumatic, and hydraulic applications. Overview: - Ability to resolve problems efficiently in a professional, prompt, and courteous manner - Ability to work to tight deadlines…
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
3D Printing, 3D Scanning, Additive Manufacturing, Products and Services
Division Leader – Effective Technology Consultant – Product Value Identification - Strategic Planning – Direct Contributor – New Product Development – Market Analysis Productive Group Leader with expansive experience as Sales Team Executive, AM Product Expert, Direct Contributor, and Project…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…