Regulatory Affairs Associate, Lead
Responsibilities Prepares and submits FDA correspondence including IND/IDE applications, relevant study documents...
Responsibilities Prepares and submits FDA correspondence including IND/IDE applications, relevant study documents...
verification and data calls from PEO(A). Update IBONS, IDE Program Charts (Floor Plan, Spend Plan, Coffee Mess, & Personnel Files...
, Human Subjects Research, and IND/IDE regulatory requirements. It is important that the candidate have experience working...
is a plus. Experience with design tools such as LTSPICE and Cube IDE is desired Electrical Engineer - Immediate need. Apply today!...
, CSS, DHTML, HTTP and RESTful, Git, Ant/Maven, Eclipse IDE, Linux, PostgreSQL, jQuery, microservices and docker containers...
regulatory filings, e.g. Original PMA, IDE, Design Dossier Must have a working knowledge of FDA, ISO, QSR, and EU regulations...
clinical research experience with Class III Medical Devices including PMA, IDE and 510(k) Good computer skills in usage of MS...
including PMA, IDE and 510(k) Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical...
, ISO 14971), regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs), Corrective Actions - Preventative Actions...
, ISO 14971), regulatory filings (FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs), Corrective Actions – Preventative Actions...