Director, Regulatory Affairs – Regenerative Medicine & Biologics Quality
, including however not limited to: Regulatory Submissions (e.g., IND, BLA, & pre-RFD, 510(k), IDE, PMA, Technical Documentation...
, including however not limited to: Regulatory Submissions (e.g., IND, BLA, & pre-RFD, 510(k), IDE, PMA, Technical Documentation...
to work well as part of a team Strong written and verbal communication skills Knowledge of Visual Studio IDE and Windows SDK...
working with MAVEN as Build tool;log4j for logging;Splunk for log aggregation/troubleshooting & STS/Eclipse as IDE;agile...
of demonstrated in-depth experience developing, testing and debugging software for Windows OS using Visual Studio IDE and Windows... Knowledge of Visual Studio IDE and Windows SDK languages are preferred * Knowledge of risk management methodologies...
Lead to ensure end-to-end software quality across the development lifecycle for systems supporting IDE clinical... File (DHF) deliverables are complete and audit-ready Support IDE clinical study readiness, including configuration...
, and PCB design software (Altium, KiCAD, or Eagle) FPGA design, both device hardware and IDE software: Altera, Xilinx, Actel...
project(s). Manage compliance for required reporting, including but not limited to IDE annual reports, clinicaltrials.gov...
and containerization technologies. Experience with IDE/OS/Development Frameworks: Qt Enterprise. Linux (RHEL). Windows Desktop...
Integrated Development Environment (IDE) and Event Execution System (EES) hardware and software patching reviews and deployment...
works like an IDE to emulate real-world scenarios and is easily personalized to specific team needs, ensuring a positive...