Enterprise customer's needs and design product solutions Work across all the stack: infra, frontend client, backend, web, IDE...
submissions (Q-Sub, PMA, IDE) to FDA and other global regulatory agencies. Experience negotiating with regulatory authority...
to reproduce in development environments Familiar with debugging code using an Integrated Development Environment (IDE...
(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...
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...
) Required – Expert knowledge of SQL or comparable data querying language Required – Expert knowledge of Git and Development IDE...
#, Javascript and/or other script languages Familiarity with the Visual Studio Code IDE Game knowledge and an understanding...
#, Javascript and/or other script languages Familiarity with the Visual Studio Code IDE Game knowledge and an understanding...
Qualifications: Working knowledge of FDA IDE/IND submission process, eCRIS, eIRB, and experience with REDCap. Familiarity...