At Calimontex Technologies LLC, I prepared regulatory documents for Class II/III medical devices and supported FDA 510(k) and eSTAR submissions. I also maintained design history files, CAPA, change control, FMEA, GUDID, and labeling records.
At VIATRIS, I managed regulatory submissions across US, EU, and GCC markets and led a team of five to improve submission turnaround time. I published global regulatory dossiers using Lorenz docuBridge and coordinated protocol amendments and safety reports.
At DXC TECHNOLOGY, I coordinated regulatory and clinical document submissions and prepared clinical study reports, investigator brochures, study protocols, and IND documentation. For a Northeastern University project, I developed a Phase II oncology clinical trial protocol and prepared IRB submission documents, protocol amendments, and safety reports.
