Sindri Kristjánsson

Project Manager at Lyfjastofnun / Icelandic Medicines Agency
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Contact Information
us****@****om
(386) 825-5501
Location
Iceland, IS

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Experience

    • Iceland
    • Government Administration
    • 1 - 100 Employee
    • Project Manager
      • Feb 2023 - Present
    • Iceland
    • Professional Services
    • Owner
      • Sep 2022 - Present

      A professional practice that gives expert advice within the pharmaceutical and medical device field in Iceland. An experienced professional that is able to offer unique insights into Icelandic regulatory affairs in the areas of both medicinal products and medical devices to be placed on the Icelandic market. A professional practice that gives expert advice within the pharmaceutical and medical device field in Iceland. An experienced professional that is able to offer unique insights into Icelandic regulatory affairs in the areas of both medicinal products and medical devices to be placed on the Icelandic market.

    • Environmental Services
    • 1 - 100 Employee
    • Legal Advisor
      • Sep 2022 - Feb 2023
      • Sep 2018 - Aug 2022

      Legal counsel for executive director and management board of the Agency, supervision of stakeholder communication in administrative procedure, supervision and execution of communication with other authorities including, but not limited to, Icelandic parliament (Alþingi) and various ministries. Legal counsel for inspection and licensing Units of the Agency.

      • Sep 2017 - Aug 2018

      Head of Unit at the Icelandic Competent Authority responsible for medicinal products and medical devices. The Inspections Unit at IMA is responsible for inspecting and issuing authorisations for manufacturers and wholesalers of medicinal products in Iceland. Other areas of responsibility include inspections of pharmacies, veterinary pharmacies, hospital pharmacies, classification of borderline products, market surveillance for medical devices and more.

      • Aug 2015 - Aug 2017

      Legal counsel for executive director and management board of the Agency, supervision of stakeholder communication in administrative procedure, supervision and execution of communication with other authorities including, but not limited to, Icelandic parliament (Alþingi) and various ministries. Legal counsel for inspection and licensing Units of the Agency.

      • Apr 2014 - Aug 2015

      Legal counsel for executive director and management board of the Agency, supervision of stakeholder communication in administrative procedure, supervision and execution of communication with other authorities including, but not limited to, Icelandic parliament (Alþingi) and various ministries. Legal counsel for inspection and licensing Units of the Agency and revision of insurance parameters of clinical trial applications.

    • Legal advisor
      • Mar 2011 - Mar 2014

      Roles and responsibilities as legal advisor at the Ministry of Health focused mainly on medicinal products and medical device legislation. Tasked with all communication with the EFTA Secretariat on those two subjects regarding transposing and implementing EU legislation that was incorporated in the EEA Agreement. Also tasked with writing draft legislation (bills to be submitted to the parliament and draft regulations). Roles and responsibilities also covered areas regarding blood and blood components and tissues and cells, e-health issues and radiation protection. Show less

    • Switzerland
    • International Affairs
    • 1 - 100 Employee
    • Legal Trainee - Financial Mechanism Office
      • Sep 2010 - Feb 2011

      Traineeship in the legal department of the EFTA FMO. Main tasks, but not limited to, grant agreement management, e.g. note taking during grant agreement management board meetings, drafting grant agreement addenda, and follow up. Traineeship in the legal department of the EFTA FMO. Main tasks, but not limited to, grant agreement management, e.g. note taking during grant agreement management board meetings, drafting grant agreement addenda, and follow up.

Education

  • Háskólinn á Akureyri
    M.L., Law
    2008 - 2010
  • Háskólinn á Akureyri
    BA, Law
    2005 - 2008

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