Experience

Matrix Medika

• Israel
• Medical Device
• 1 - 100 Employee

• VP QA/RA

  • Jul 2021 - Present

• QA/RA Director

  • Feb 2021 - Present



DarioHealth

• United States
• Wellness and Fitness Services
• 200 - 300 Employee

• QA/RA Director

  • May 2019 - Feb 2021

• QA/RA Manager

  • Jul 2018 - May 2019

  + Manages the Quality Management System including Develop and maintain the Company's QMS and procedures to meet ISO 13485, ISO 62304, ISO 14971, IVDD as well as FDA (QSR), TGA (Australia), and Health Canada o SME in External Audits and experience with Notified Body and MDSAP auditso Managing QMS processes as change orders (CO), internal audits and Corrective & Preventive actions (CAPA)o Presenting inputs in Management Reviewo Auditing Suppliers and Subcontractorso Provide trainings as required+ Responsible for pre & post market regulatory activities (regulatory assessments and submissions, reportable events, field actions)o Perform regulatory assessments for new / revised products and support design and development of products from a regulatory perspective.o Review promotional material and labeling for regulatory compliance. o Write, update and maintain technical files.o Prepare regulatory submissions / document rationales (letters to file) for modifications when appropriate (worldwide).o Assessment of potentially Reportable Events, Field Actions & Recalls worldwide.o Submit MDR, Vigilance, and other device reports to appropriate worldwide regulatory agencies and authorities. Show less

• RA Specialist

  • Feb 2018 - Jun 2018

• QA Specialist

  • Jul 2016 - Jan 2018



Q Core Medical Ltd.

• Israel
• Medical Equipment Manufacturing
• 1 - 100 Employee

• QA Engineer

  • Jan 2015 - Jun 2016



Trupharm marketing L.t.d

• QA & RA Engineer

  • Jul 2014 - Jan 2015



Protalix Biotherapeutics

• Israel
• Biotechnology Research
• 100 - 200 Employee

• Quality Assurance Engineer

  • May 2012 - Jul 2014



Perrigo Company plc

• Ireland
• Manufacturing
• 700 & Above Employee

• quality assurance student

  • Sep 2009 - Sep 2011