Experience

Sanoculis Ltd.
• Israel
• Medical Device
• 1 - 100 Employee
• RA Specialist

  • Mar 2023 - Present


IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Associate Consultant

  • Jan 2022 - Mar 2023

  I am a Quality Assurance and Regulatory Affairs consultant at IQVIA MedTech Regulatory Solutions, Israel. My responsibilities include assisting clients with:-Establishment, implementation, and maintenance of Quality Management System in accordance with EN ISO 13485:2016, EU MDR (2017/745), and FDA QSR.- Control and maintenance of quality procedures & forms.- Preparation of a Technical File, including for a SaMD (IEC 62304:2006)- CAPA handling.- Preparations & Participation in internal and external audits, including MDR CE Certification.- Managing regulatory processes in liaison with regulatory authorities (Israeli MoH), FDA US Agent, EU Authorized Representative.- AMAR submissions to the Israel MOH, and CFS submissions to the Israel Export Institute. Show less

• Associate Consultant

  • Jan 2021 - Dec 2021

  QMS Coordinator - Assistance in preparation of RA/QA documentation in accordance with ISO 13485 / EU regulatory framework.Supporting integration of IT systems during company’s merging process.AMAR submissions to the Israel MOH, and CFS submissions to the Israel Export Institute.Business Development, marketing & events coordinator, facilitator activity.



MedicSense Ltd.

• United Kingdom

• Associate Consultant & Business Development

  • Jun 2016 - Dec 2020

  QMS Coordinator - Assistance in preparation of RA/QA documentation in accordance with ISO 13485 / EU regulatory framework. Management and development of the "Aspect Knowledge Center" training program. Supporting integration of IT systems during company’s merging process. AMAR submissions to the Israel MOH, and CFS submissions to the Israel Export Institute. Business Development, marketing & events coordinator, facilitator activity. QMS Coordinator - Assistance in preparation of RA/QA documentation in accordance with ISO 13485 / EU regulatory framework. Management and development of the "Aspect Knowledge Center" training program. Supporting integration of IT systems during company’s merging process. AMAR submissions to the Israel MOH, and CFS submissions to the Israel Export Institute. Business Development, marketing & events coordinator, facilitator activity.



Mercury Scientific and Industrial Products ltd

• Israel
• Chemical Manufacturing
• 1 - 100 Employee

• Customer Relations Representative

  • Mar 2013 - Jun 2016

  Support of full customer chain from the first contact (emails, online chats, telephone) to the product arriving at the customers'​ doorstep and on-wards (post sale). Including:- a. Managing PO's & Proposals. b. Customer complaints handling. c. Documenting customers'​ requests, and providing creative solutions. d. Working in a multi-tasking and dynamic environment. e. Working with multiple interfaces to comply with the customers'​ needs. f. Sales orientation. g. Coordinating technical support at customers'​ location. h. providing alternative solutions. Show less



Kinrot Ventures

• Laboratory Specialist

  • Aug 2010 - Aug 2011

  R&D of a non reagents ecological method for water and waste water disinfection based on electrical pulse discharge into the water. *microbiological experiments - This position required planning and executing microbiological experiments, coordinating results' acquisition, data processing, summarizing and concluding it for further research. R&D of a non reagents ecological method for water and waste water disinfection based on electrical pulse discharge into the water. *microbiological experiments - This position required planning and executing microbiological experiments, coordinating results' acquisition, data processing, summarizing and concluding it for further research.



Kolmir Water Technologies Ltd.

• Israel
• Renewables & Environment

• Laboratory Specialist

  • Aug 2010 - Jun 2011

  R&D of a novel contact-less water filtering technology using ultrasound energy, under the leadership and guidance of Prof. Yuri Kolodny. Water & Waste-Water experiments - This position requires diligent planning and execution of experiments, results acquisition, data processing, summarizing and concluding it for further research. As part of the above, I took a part in planning the next generation of the new laboratory scale device needed for the company. I have acquired experience in water and waste-water analysis methods in accordance with “Standard Methods for the Examination of Water and Waste-water”, including Turbidity, Oxidation-Reduction potential, Electrical conductivity measurements, Jar test, and TSS analysis. Show less



Ben Gurion University

• Canada
• Higher Education
• 1 - 100 Employee

• RESEARCH STUDENT, RO membranes

  • Oct 2006 - Oct 2009

  Theses subject - Incorporation of Aquaporins in Membranes for Industrial Water Purification/Desalination. RO membranes, polymers, AFM, ATR-IR, Langmuir-Blodgett ,Fluorescent microscopy, Ellipsometry, GIXD at European Synchrotron Radiation Facility - Grenoble, purifying proteins and performing procedures under sterile conditions. SDS-Page, Chromatography, Spectrophotometry, Sucrose gradient centrifugation, Cell cultures, Liposome encapsulation, basic knowledge of GC, HPLC, ELISA, microbiology. Show less