high-quality IDE and PMA submissions, while remaining sufficiently hands-on to provide technical oversight and mentorship... regulatory representative to FDA CDRH for IHC CDx programs Lead FDA Pre-Submission (Q-sub), IDE, and PMA interactions...
and success in IDE studies and neurovascular therapeutic area. Extensive knowledge of FDA requirements, GCPs, other regulatory...
in Visual Studio IDE, GCC compilers / Makefiles Proficient in Windows, UNIX/Linux Software Engineering Concepts & Processes...
in Visual Studio IDE, GCC compilers / Makefiles Proficient in Windows, UNIX/Linux Software Engineering Concepts & Processes...
IdentityNow. Experience with Java, PowerShell, LDAP, ServiceNow, Postman, VSCode IDE, JSON, Velocity Template Language (VTL...
in Visual Studio IDE, GCC compilers / Makefiles Proficient in Windows, UNIX/Linux Software Engineering Concepts & Processes...
commands, hooks, settings configuration, and IDE integrations. Hands-on experience building agents using the Anthropic Claude...
, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR) Education & Experience: 10... preferred) Experience supporting IDE, PMA, or similar regulatory pathways with understanding of clinical evidence requirements...
, Force.com IDE, Data Loader, schedule/ batch jobs, Rest API, and email services. Responsible for testing and implementation...
IBM SPSS – Statistical analysis software for business analytics users PyCharm – Professional Python IDE for analytics...