Samuel Shimp
Associate Director Regulatory Affairs @ CERENOVUS | Medical Devices: FDA, EU MDR, UKCA, MDSAP, ISO 13485
- Role
- Associate Director Regulatory Affairs at Johnson & Johnson MedTech
- Location
- Williamsburg, VA, US
- LinkedIn followers
- 500 followers
About Samuel Shimp
Our team at J&J MedTech Neurovascular, under my leadership as Associate Director of Regulatory Affairs, excels in navigating complex regulatory landscapes in the US and EU/UK markets, ensuring approved / cleared pre-market filings, successful external audits for Regulatory Compliance, and compliant product labeling (Instructions for Use). With a PhD in Biomedical Engineering and specialized skills in FDA Class II and device submissions, EU MDR and UKCA Technical Documentation filings, and compliance to ISO 13485 and MDSAP, we foster innovation in medical devices while adhering to stringent global standards.My journey in Regulatory Affairs began over a decade ago, and it is marked by a steadfast commitment to patient care through the regulatory approval of cutting-edge neurological devices. This dedication, paired with fluency in English and Spanish, enables us to support our regulatory teams worldwide, facilitating international collaboration and achieving regulatory excellence.
Experience
Associate Director Regulatory Affairs
Sep 2022 — Present · Williamsburg, VA, US
Soy un líder de un equipo de Asuntos Regulatorios responsable de las sumisiones regulatorias y la documentación de - Cambios en ciclo de vida de productos (mejora de costos, cambios de proveedores, etc.)- Contenido de IFU y etiquetado directo al paciente que cumple con las regulaciones MDR de la FDA y la UE - Desarrollo de nuevos productos Mi equipo es directamente responsable de las sumisiones regulatorias para los EE. UU. y la UE.(PMA, HDE, IDE, 510(k), EU MDR y UKCA. Apoyamos a los equipos regulatorios de todo el mundo para cumplir con los requisitos regulatorios globales. También brindamos soporte a auditorías externas para MDSAP, ISO 13485, MDR y UKCA.
Education
Virginia Tech
M.S., Mechanical Engineering
2006 — 2008
Clark College
Associate of Arts - AA
Virginia Tech
Ph.D., Biomedical Engineering
2008 — 2012
Brigham Young University
B.S., Mechanical Engineering
2003 — 2006
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