) Processes Customer Service Improvement, Data Entry, Data Storage, Drawing, Eclipse IDE, Error Detection, Financial Processing...
and registration strategies Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/IDE/PMA, as applicable...
Supports the preparation, conduct and follow-up of BIMO audit readiness in relation to monitoring of the IDE trials May...
dossiers (e.g., PMA/510(k)/BLAs in the U.S., CE/UKCA in Europe, PMA equivalents internationally, IDE/Clinical submissions...
in working with Visual Studio, an integrated development environment (IDE) for software development. Ability to manage stress...
ServiceNow platform capabilities (Studio IDE, Mobile, Automated Test Framework, Delegated Development, Flow Designer, Source...
communication skills. Have experience preparing Human Factors information for 510(k), BLA, IDE, and PMA submissions...
. IDE tools – Eclipse, IntelliJ Web Service development experience (REST/JSON, SOAP) Java – Core, Enterprise Spring...
platforms. Proficient in C/C++ firmware development, and IDE tools. Working knowledge of hardware interfaces: UART, SPI, I2C...
, and Engineering teams to ensure compliant implementation of changes. Support IDE-related activities as needed, including amendments... System Regulation (21 CFR 820), and change control processes. Experience supporting IDE submissions or amendments....