management or execution of regulatory submission activities, including IDE, PMA, and EU MDR CE marking Excellent research...
trials preferred (TAVR in particular). Investigational Device Exemption (IDE) trial experience. Physician management...
systems such as Oracle, SQL Server, DB2 Experience with Eclipse IDE and Spring Framework (Boot, MVC, WebFlux...
requirements Experience developing using Eclipse IDE with Force.com Plug-in and Force.com IDE, Visual Studio, and Visual Studio...
of experience with APIs (JSON, XML, SOAP, etc) 5+ years IDE experience with Microsoft Visual Studios, IntelliJ, or similar IDE 2...
and ability to articulate clearly Knowledge of common computer languages (C, C++, Python) and software development tools (Version control, IDE...
that may include;IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory...
Qualifications: Working knowledge of FDA IDE/IND submission process, eCRIS, eIRB, and experience with REDCap. Familiarity...
testing platform using test scripts with Eclipse IDE, writing Selenium Webdriver scripts using TestNG Strong coding skills...
within assigned schedule. Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMA's, contributes...