Moria Zigman

Regulatory Affairs Specialist at TytoCare
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Contact Information
us****@****om
(386) 825-5501
Location
Israel, IL
Languages
  • English Professional working proficiency
  • Hebrew Native or bilingual proficiency

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Experience

    • United States
    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Regulatory Affairs Specialist
      • Oct 2021 - Present

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Regulatory Affairs Specialist
      • Jun 2020 - Jan 2022

    • United Kingdom
    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Senior Regulatory Affairs Officer
      • Sep 2017 - Apr 2020

    • Medical Device
    • 700 & Above Employee
    • Regulatory Affairs Consultant
      • Apr 2017 - Sep 2017

      Responsible for updating and maintaining over 40 Technical Files for Class I, I measuring and IIa Dental Medical Devices according to internal requirements and Medical Devices Regulation QMS GAP analysis according to ISO 13485:2016 standard Collaborating with subcontractors for relevant data collecting Advising in various regulatory issues Responsible for updating and maintaining over 40 Technical Files for Class I, I measuring and IIa Dental Medical Devices according to internal requirements and Medical Devices Regulation QMS GAP analysis according to ISO 13485:2016 standard Collaborating with subcontractors for relevant data collecting Advising in various regulatory issues

    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Regulatory Affairs
      • Oct 2012 - Aug 2016

      Responsible for new registrations and renewal of existing registrations of various markets such as Asia, the Middle East, Latin America, Canada and Europe. Experienced with Medical Devices from Class I, IIa, IIb and III. In charge of technical files preparation and maintenance. Job included ongoing work with various departments such as R&D, QA, Marketing, Sales, Production. Responsible for new registrations and renewal of existing registrations of various markets such as Asia, the Middle East, Latin America, Canada and Europe. Experienced with Medical Devices from Class I, IIa, IIb and III. In charge of technical files preparation and maintenance. Job included ongoing work with various departments such as R&D, QA, Marketing, Sales, Production.

    • Research Assistant
      • Jan 2011 - Sep 2012

      Took responsibility for researching, collecting and analysing data, wrote and delivered proposals, used a number of analysis devices including Spectrophotometer, Zeta potential Took responsibility for researching, collecting and analysing data, wrote and delivered proposals, used a number of analysis devices including Spectrophotometer, Zeta potential

    • Research Assistant
      • Jan 2010 - Jan 2011

      Supported key reports with detailed use of Biochemistry research methods, applied skills in the operation of the H-NMR system and results analysis Supported key reports with detailed use of Biochemistry research methods, applied skills in the operation of the H-NMR system and results analysis

Education

  • Bar-Ilan University
    Bs.c, Pharmaceutical Chemistry
    2006 - 2010

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