established processes and procedures. Preferred Qualifications SAP HANA DB 2.0 admin tools (XS Admin, Web IDE, HANA Studio...
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...
in Visual Studio IDE, GCC compilers / Makefiles Proficient in Windows, UNIX/Linux Software Engineering Concepts & Processes...
, IND, and IDE submissions and maintenance. Participates in planning, development, coordination, and implementation...
not limited to: Regulatory Submissions (e.g., 510(k), IDE, PMA, IND, BLA, & IND, Technical Documentation, STED, CERs...
, ICH guidelines, ISO 14155, FDA IDE/PMA regulations, and EU MDR clinical investigation requirements;experience with multi...
and phases including IND or IDE held investigator initiated trials. (30%) Manage regulatory processes to maintain compliance...
, 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...
Studio required Familiarity with Microsoft Visual Studio IDE's and the STL Library Proficiency with a source code control...
commands, hooks, settings configuration, and IDE integrations. Hands-on experience building agents using the Anthropic Claude...