Sr. Manager, Regulatory Affairs
(k) Notifications. Additional experience with IDE and De Novo submissions is a plus. Must have demonstrated ability to mentor...
(k) Notifications. Additional experience with IDE and De Novo submissions is a plus. Must have demonstrated ability to mentor...
. Proficient knowledge of software tools supporting Integrated Development Environments (IDE), version control, defect reporting...
revenue of billable services. Conduct research analysis, IDE compliance and billing follow up. Minimum qualifications...
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...
and/or Linux distributions 5 years of experience in Gitlab or IDE tools 5 years of experience in software development...
may support investigator-initiated Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications...
/SAS: Perform IDE walk-through;shortcuts Connect to data bases Use functions such as classes, variables, lists...
systems 60 months experience with Java programming in an IBM environment using IDE of IBM’s Rational Application Developer...
Integrated Development Environment (IDE) and Event Execution System (EES) hardware and software patching reviews and deployment...
Responsibilities: Develop and execute U.S. regulatory strategies to support product submissions (e.g., IDE, 510... experience with FDA submissions (510(k), IDE, or PMA) and direct interaction with FDA reviewers. Solid understanding of U.S. FDA...