Dr. Ebot Eyong is a proven senior consultant in regulatory affairs and quality assurance engineering for advanced Medtech, Biotech, and pharmaceutical product development. A result-oriented Biomedical Engineer with more than 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 major stakeholders in the healthcare industry and implementing strategies that ensure swift market access approvals and clearances for new products into existing and emerging markets (AMERS, APAC, LATAM, EMEA, ASEAN, META). He has also managed remediation projects involving non-compliant observations, warning letters, and recall actions. His ability to communicate and delegate functions across stakeholders and execute streamlined deliverables at competitive levels has earned great recognition. 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. His newest book, “MED-CHAINS “shares innovative re-engineering insights in solving pandemic crises worldwide.
http://eyongee.com
https://www.youtube.com/watch?v=IeRHPBSA9ok

**Some outstanding 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, USA
SME in developing and implementing regulatory strategies for assigned programs (Global & EU MDR Labeling and RA Submissions), ensuring cross-functional alignment to regulatory compliance and effectively addressing deficiencies

ZOLL Medical Corporation, USA
Managed the original PMA and gained FDA approval for the LifeVest Wearable Defibrillator in a record timeframe.

Sherpa Meddev, USA
Reviewed and evaluated regulatory documentation. Managed quality management system to ensure compliance with new FDA and EU regulations.

Autem Therapeutics, USA
Managed design controls per ISO requirements to resolve regulatory and quality issues.

Knoell, USA
Reviewed design and change controls, led discussions with regulatory bodies, prepared and supported timely submissions/approvals and resolved regulatory compliance issues.

Philips Healthcare, USA
Subject Matter Expert (SME) in managing worldwide regulatory compliance requests and submissions on remediation of medical devices.