A proven senior consultant in regulatory affairs and quality assurance engineering for advanced Medtech, Biotech, and pharmaceutical product development. A result-oriented Biomedical Engineer and Regulatory Affairs Leader with 20 years of experience in Global Quality and Regulatory Strategy, Compliance, and Regulatory Submissions (510K, PMA, IDE, EUMDR/IVDR, CTAs, IND, NDA, BLA, eCTD 4.0, etc.). As a senior principal consultant for E&E Medicals and Consulting, he has dedicated his career to working with the major stakeholders in the Healthcare Industry with an exceptional record of gaining regulatory approvals and clearances for new products in existing and emerging markets (AMERS, APAC, LATAM, EMEA, ASEAN, META). Managing remediation activities involving observations/warning letters/recall actions, including cross-functional communication and delegation of responsibilities across stakeholders and executing streamlined deliverables at competitive levels. Dr. Eyong earned his doctorate in Engineering Management from Walden University and postdoctoral studies in Digital Health and Data Science applications at Harvard Medical School. Dr. Eyong's newest book, titled MED – CHAINS & COVID-19: Innovative Solutions for Pandemics, a thoroughly researched approach to pandemics, employs the expertise of respected medical researchers, acclaimed scientists, and innovative medical device and drug developers across the industry.website: http://eyongee.com----------------------------------------Currently running and other completed projects:Integra LifeSciences, USA Advising senior regulatory affairs executives on decision-making and strategy on regulatory pathways/Submissions for Fast-track product clearances and approvals into global markets.Baxter International, USASME in development and implementation of regulatory strategies for assigned programs (Global & EU MDR Labeling and RA Submissions)ensuring cross-functional alignment to regulatory compliance and deficiencies.ZOLL Medical Corporation, USAManaged the original PMA submission (180 days) to approve the LifeVest Wearable Defibrillator in a record timeframe.Autem Therapeutics, USAManaged Design Controls per ISO requirements to resolve regulatory issues.Knoell USA, USAReviewed change controls,leading discussions with regulatory bodies, including preparing and supporting timely submissions for approvals and resolving issues with regulatory compliance.Philips Healthcare, USA Subject Matter Expert (SME) in Managing worldwide regulatory compliance requests and submissions on remediation projects.