Medical Safety Specialist II
(GCP, ISO 13485, ISO 14971) Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs) Corrective Actions...
(GCP, ISO 13485, ISO 14971) Regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs) Corrective Actions...
supporting Integrated Development Environments (IDE), version control, defect reporting and scripting. Proficient with developer...
III, you will assess cloud infrastructure and cloud service needs for an Integrated Digital Environment (IDE), assist... in assessing the integration of existing custom IDE's implemented on Amazon Web Services and Azure throughout the U.S. military...
with in IDE like IntelliJ , VS Code, etc. Skills: Proficient in programming in one or more industry-standard languages (e.g...
generative AI technologies including Kiro IDE and Amazon Q Developer that are transforming the software development landscape... AI and foundation models. We're leveraging the latest advances in AI to transform how engineers work from IDE environments to web-based...
) Required – Expert knowledge of SQL or comparable data querying language Required – Expert knowledge of Git and Development IDE...
, and compliant. You're role with the company: Prepare and support U.S. (IDE, PMA, 510(k)) and international (EU MDR, Health... submissions (IDE, PMA). Detail-oriented, organized, and able to manage multiple projects in a fast-paced environment. * Up to 10...
management, core labs) Manage patient screening process along with the internal heart team Ensure compliance with GCP, FDA IDE... IDE submissions, EU approvals, and IRB/EC communications Assist in preparing responses to regulatory queries...
Interfaces (APIs). Use integrated development environment (IDE) tools such as Microsoft Visual Studio to develop websites, web...
#, Javascript and/or other script languages Familiarity with the Visual Studio Code IDE Game knowledge and an understanding...