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...
MES WIP BOM User Interface HMI Systems Wonderware SMC Intouch Viewer Intouch Maker ArchestrA IDE ArchestrA...
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...
hardware or to improve its performance. – Java development using the Eclipse IDE (Integrated Development Environment...
that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory...
for software components. – Java development using the Eclipse IDE (Integrated Development Environment). – Development of Java 2...
of design decisions. – Java development using the Eclipse IDE (Integrated Development Environment). – Development of Java 2...
Eclipse IDE (Integrated Development Environment). – Development of Java 2 Enterprise Edition (J2EE) applications...
research methods and operations, the Institutional Review Board, the Food and Drug Administration IND and IDE submission...
. – Use of orchestration frameworks such as Spring and Kafka. – Java development using the Eclipse IDE (Integrated Development Environment...