Director, Regulatory Affairs Strategy
international regulatory submissions and registrations. Working knowledge of IDE/IND/NDA regulations. Accountable author...
international regulatory submissions and registrations. Working knowledge of IDE/IND/NDA regulations. Accountable author...
capabilities (Studio IDE, Mobile, Automated Test Framework, Delegated Development, Flow Designer, Source Control, APIs...
and measure outcomes and consequences of design decisions. Java development using the Eclipse IDE (Integrated Development...
/IDE submissions, FDA guidance, and clinical protocol regulatory documentation. â— Experience leading or mentoring a team..., structure, and format across IIT protocol templates and related regulatory documents. â— Support IND/IDE submissions...
in-depth experience developing, testing and debugging software for Windows OS using Visual Studio IDE and Windows SDK...
and automated testing environments Selenium, Junit, Karate, Cucumber, and TestNG Java, Python, and JavaScript IntelliJ IDE GIT...
/IDE submissions, FDA guidance, and clinical protocol regulatory documentation. â— Experience leading or mentoring a team..., structure, and format across IIT protocol templates and related regulatory documents. â— Support IND/IDE submissions...
/IDE submissions, FDA guidance, and clinical protocol regulatory documentation. â— Experience leading or mentoring a team..., structure, and format across IIT protocol templates and related regulatory documents. â— Support IND/IDE submissions...
through different study phases (pre-IDE, IDE submission, site selection and activation, study execution, data analysis...
deliverables. Ensure readiness for IND/IDE/PMA/510(k) touchpoints in partnership with Regulatory/QA. Embed FDA QMSR/21 CFR 820...