Aisha Sarwary Email & Phone Number

Irvine, California, United States

Supporting 510(k) submission for IVDs

Camarillo, California, United States

EU MDR lead RA. Compiling and submitting technical documents. Preparing for stage 1 audit. Registering class IIa implantable device (8201). Registering class IIa temporary 3D resin material (1209).

Camarillo, California, United States

Support the team with global product registrations for new and existing products by timely submitting registrations. Develop and revise Standard Operating Procedure (SOPs) to improve regulatory compliance of the quality management system. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity. Participant in MDSAP stage 3 recertification audit. Responsible for implementing corrective actions and responding to the regulatory agency.Compiling technical documents for EU MDR.

Camarillo, California, United States

Coordinate, investigate, and analyze product complaints and nonconformances. Document root cause analysis investigations and present findings. Continuously monitor analytical chemists to improve analytical data reporting, adhering to GDP and cGMP and to increase efficiency, compliance and quality. Administer the document control system including documentation and tracking requests, approvals, and implementation.

Los Angeles, California, United States

Concern: Due to the pandemic and staffing shortages, management moved patient resource workers (remote financial eligibility workers) to a centralized location. Does having a remote PRW delay care and impact service for walk-in patients?Action: Observed both the dental clinic and patient access center and conducted interviews. Gathered notes and insights from GEMBA to create a process map delineating financial responsibilities between clinic clerks and PRWs’. Collected data in the form of time stamps regarding the financial eligibility process and performed analysis of average financial clearance times. Found that a remote PRW improves productivity and does not delay care.

Los Angeles, California, United States

Concern: What can be done to reduce the patients’ waiting time based on the existing system and data? Action: Conducted a deep analysis of CHLA surgery scheduling data base to provide surgeons a better understanding of how much time it takes them to perform procedures. In addition, our analysis allowed us to find the rate of how often the scheduling centers accurately scheduled procedures by looking at the scheduled procedure times and actual procedure times. Utilized LEAN tools to identify strong points of waste (ex. Waiting for lab results during pre-op) and then developed process to avoid delays.

Los Angeles Metropolitan Area

Designed and implemented a cohesive database in Excel to track hospital utilization trends during/post-covid Conducted literature reviews to understand current covid long haul results Produced blogs summarizing healthcare consolidation trends among states

Simi Valley, California

Completed intensive training on the U.S. healthcare system and practical hands-on patient care. Assisted and interacted with patients. Assisted with patient care tasks such as bathing, feeding, changing, ambulating, and checking vitals under the supervision of a licensed staff member.

Simi Valley

Master Of Science - Ms, Regulatory Sciences

Bachelor Of Science - Bs, Public Policy (Emphasis In Health Policy And Management), 3.59 Gpa