Mooud Amirkavei

- Prepare regulatory submission documents (510(k), technical files) for medical devices to USA, Canada, EMEA, APAC and Rest of World (ROW) - Knowledge of EU and International Medical Device Regulatory Requirements. Determination of medical device classifications and regulatory pathways and strategy - Profound understanding of quality management systems and standards (ISO 13485, EC, IEC 82304-1, IEC 62304) - Experience working with SaMD in treatment planning systems, oncology information systems, mobile apps

- Demonstrated a new therapeutic strategy in age-related neurodegenerative diseases for protein degradation pathway - Developed a novel near-infrared laser heating system for mouse eye - Executed pre-clinical study in Pig as closest model to human eye - Designed, implemented, and troubleshot experiments - Conducted tissue processing procedure, IHC and H&E staining, and microscope imaging - Supervised 5 bachelor theses

- Investigated transcriptional regulations of cells in response to heat - Designed PCR arrays for 6 different pathways - Designed and optimized protocols to determine protein and gene expression from cultured cell and tissue by WB & qPCR

- Compiled regulatory submission packages for medical device regulatory bodies including FDA, Health Canada, Australian TGA - Made drafts of development project regulatory and compliance plans - Participated in preparations and supporting the backroom in an FDA inspection and Notified Body audit - Acted as change Analyst for Quality System documents - Assisted with the document approval requirements of an ISO13485/FDA QSR Quality Management System

Optimized parameters for synthesizing phospholipid biomembrane models analyzed by MS/MS spectrometry

- Conducted validation, routine performance, process, and analytical method development to support final products - Generated and reviewed documents used to support GMP

- Maintained data integrity and ensured compliance with company SOPs and GMP - Compiled data into relevant data management systems - Authored, reviewed SOPs, reports, protocols, investigations, change controls, and data summaries