Sr. Principal Consultant, RA/QA Project Manager & Program Director
A highly accomplished Sr. Principal Consultant with nearly two decades of extensive hands-on experience in Regulatory Affairs and Quality Assurance for medical devices and combination products. Dr. Ebot possesses a dynamic background encompassing authoring and compiling complex submissions (510K, PMA, de Novo, IDE, EUMDR/IVDR, CTAs), Design/Change Controls, Quality Management Systems, clinical tri...
Experience: 18+ years
Submissions: 50 510(k), 10 De Novo, 5 PMA
Eyong Ebot provides regulatory consulting services to clients in:
Holding advanced degrees from prestigious institutions including Harvard University and Walden University, this consultant possesses a robust educational foundation in Digital Health and Data Science, alongside specialized knowledge in Engineering Management, Regulatory Affairs, and Quality Assurance. Their academic achievements underscore a deep understanding of complex technical and regulatory landscapes, directly benefiting medtech companies seeking to navigate intricate product development and approval processes.
As an active member of the Regulatory Affairs Professionals Society (RAPS) and the American Society for Quality (ASQ) Biomedical Division, this consultant maintains strong connections within the medtech industry. These memberships signify a commitment to professional development and a deep engagement with current regulatory trends and best practices.
With nearly two decades of extensive experience, this Sr. Principal Consultant has a proven track record of success in Regulatory Affairs and Quality Assurance for medical devices and combination products. They have held senior roles at prominent organizations such as Baxter International and Philips Healthcare, demonstrating a consistent ability to manage complex projects and drive regulatory compliance. Their career highlights include authoring and compiling a wide range of regulatory submissions, leading QMS implementations, and providing strategic guidance on global market access.
A highly accomplished Sr. Principal Consultant with nearly two decades of extensive hands-on experience in Regulatory Affairs and Quality Assurance for medical devices and combination products. Dr. Ebot possesses a dynamic background encompassing authoring and compiling complex submissions (510K, PM...
With an impressive 18 years of dedicated experience in Regulatory Affairs and Quality Assurance, Eyong Ebot stands out as a Sr. Principal Consultant with deep expertise in medical devices and combination products. Their comprehensive background encompasses authoring and compiling a wide array of complex submissions, including 510(k)s, PMAs, and de Novos, coupled with a strong command of global regulations like EU MDR/IVDR and ISO 13485. Dr. Ebot's proficiency spans across all device classes (I, II, and III) and critical device panels such as Cardiovascular, IVD, and SaMD, including AI/ML technologies. Their proven ability to execute high-quality deliverables within set timelines, combined with a robust technical foundation and certifications like RAC, CQE, and Six Sigma Master Black Belt, makes them an invaluable asset for companies prioritizing swift and successful global market access.
This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.
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