Dr. EE Eyong is a senior engineering Consultant for advanced MedTech and pharmaceutical development. A motivated and result-oriented Biomedical Engineer and Regulatory Affairs Leader with an extensive background in new product development with 15+ years of experience in Quality Engineering, Quality Assurance, Quality Systems Implementation, Global Regulatory Strategy, Regulatory Compliance, and Regulatory Submissions(510K, PMA, IDE, EUMDR/IVDR, CTAs, IND, NDA, BLA, eCTD 4.0, etc.), with 10+ years of management experience in projects relating to new medical devices/Drugs/IVDs/ Combination devices. As a principal consultant for E&E Medicals and consulting, he has dedicated his career to working with global MedTech, pharmaceutical companies, and regulatory agencies with an exceptional record of gaining regulatory approvals and clearances for new products in existing and emerging markets (AMERS, APAC, LATAM, EMEA, ASEAN, META). He serves as Final Reviewer for Recognized FDA 510K Third Party Review Organizations. He has also managed remediation activities involving observations/warning letters/recall actions, providing project management skills, including cross-functional communication, and delegation of responsibilities across stakeholders. His Lean Six Sigma (Master Black Belt) experience facilitates executing streamlined deliverables at competitive levels. Dr. Eyong earned his doctorate in Engineering Management from Walden University. Dr. Eyong is entertaining opportunities to discuss his newest book (MED-CHAINS & COVID-19: Innovative Solutions for Pandemics). His thoroughly researched approach to pandemics employs the expertise of respected medical researchers, acclaimed scientists, and innovative medical device and drug developers across the industry.