Experience

Biometrix

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • 2015 - Present

  • updating and creating of regulatory technical files. • Working with regulatory bodies ( ISO9001 , ISO13485 , CE mark and FDA) . • regulatory submission of medical devices files to the MOH and abroad ministries of health. • Maintenance of projects under development • updating and creating Risk management,Post Marketing Surveillance,Clinical Evaluation and medical device description. • updating and creating of regulatory technical files. • Working with regulatory bodies ( ISO9001 , ISO13485 , CE mark and FDA) . • regulatory submission of medical devices files to the MOH and abroad ministries of health. • Maintenance of projects under development • updating and creating Risk management,Post Marketing Surveillance,Clinical Evaluation and medical device description.



Omrix Biosurgery Israel

• Israel
• Biotechnology Research
• 200 - 300 Employee

• Quality Control Analyst

  • Aug 2013 - Jul 2015

  ▪ Working under GMP and GLP controlled conditions • Laboratory tests Performance in chemistry and microbiology laboratory. • Check all laboratory results in IPC against the notebooks and writing COA -Certificate Of Analyses to the product. • Change Control opening, editing and updating procedures (SOP) in English . ▪ Writing protocols, and validation documents • responsible for purchase orders and equipment Lmabda- ongoing work in the priority. • coordinating temperature controlled shipments of biological samples across the country and abroad. • responsible for organizing professional training lto the team. • Construction and maintenance Archive- registered, the organization and mapping of the laboratory data archive archiving internal and external sending. • Preparation of the new-employee file with information about the company, our products and production process, biological background ,laboratory safety and more Show less



Israel Ministry of Finance

• Israel
• Government Administration
• 200 - 300 Employee

• student job at ministry of finance

  • May 2011 - Jul 2013

  • Providing a complete professional technical support to users. • Support information and computer systems, hardware and software. • Diagnostics and fault analysis, providing solutions to the users. • responsibility for quality control and customer satisfaction. • providing professional training to users. • Providing a complete professional technical support to users. • Support information and computer systems, hardware and software. • Diagnostics and fault analysis, providing solutions to the users. • responsibility for quality control and customer satisfaction. • providing professional training to users.



jerusalem ultrasound center ltd

• Israel

• Medical Assistant

  • Jun 2008 - Jun 2011

  • Pregnancy consistency responsible - taking medical measures, checking lab results and giving of responsa to the patient and others. • Administrative work activities - calendar management, ordering supplies, answering frontal and phone. • Responsible for the clinic's website includes writing medical material. • Ongoing work in the "Doctor" system. • Pregnancy consistency responsible - taking medical measures, checking lab results and giving of responsa to the patient and others. • Administrative work activities - calendar management, ordering supplies, answering frontal and phone. • Responsible for the clinic's website includes writing medical material. • Ongoing work in the "Doctor" system.