Regulatory Specialist III

with investigational new drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA. The role... for investigational new drug (IND)/investigational device exemption (IDE) or biologics applications. Provide data and document collection...

Lugar: Orlando, FL | 03/11/2024 00:11:16 AM | Salario: S/. No Especificado | Empresa: Actalent

Controls Engineer

MES WIP BOM User Interface HMI Systems Wonderware SMC Intouch Viewer Intouch Maker ArchestrA IDE ArchestrA...

Lugar: Delano, CA | 03/11/2024 00:11:58 AM | Salario: S/. $100000 - 130000 per year | Empresa: The Wonderful Company

Director, Quality Assurance

and regulatory initiatives including pharma co-development programs for clinical trial assay (CTA), IDE, 510(k), De Novo, PMA...:2016) Inspections Experience in IVD submissions with FDA (IDE, 510(k), De Novo, PMA etc) and EU (IVDR) highly desirable...

Lugar: Fremont, CA | 03/11/2024 00:11:54 AM | Salario: S/. $190000 - 230000 per year | Empresa: Personalis