Mooud Amirkavei

Berufserfahrung von Mooud Amirkavei

• Bis heute 2 Jahre und 3 Monate, seit März 2022

  RA specialist- Software as Medical Device- Digital Health

  Elekta GmbH

  - Prepare regulatory submission documents (510(k), technical files) for Class I to II medical devices and software 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)

• 7 Jahre und 8 Monate, Aug. 2014 - März 2022

  RESEARCHER/DOCTORAL CANDIDATE

  Aalto University

  - 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

• 1 Jahr und 2 Monate, Aug. 2020 - Sep. 2021

  VISITING DOCTORAL RESEARCHER

  Karolinska Institutet

  - 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

• 1 Jahr und 1 Monat, Apr. 2018 - Apr. 2019

  REGULATORY AFFAIR ENGINEER- pause from Ph.D

  PHILIPS OY

  - 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

• 7 Monate, Jan. 2014 - Juli 2014

  MASTER THESIS RESEARCHER

  GUSTAVE ROUSSY HOSPITAL

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

• 9 Monate, Mai 2012 - Jan. 2013

  Quality Assurance Specialist

  EBNESINA

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

• 1 Jahr und 7 Monate, Okt. 2010 - Apr. 2012

  QUALITY CONTROL PHARMA ANALYST

  AMIN PHARMACEUTICAL COMPANY

  - 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