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Regulatory Affairs Specialist

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Katalyst HealthCares & Life Sciences
📍 Fort Worth, United States
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Location Fort Worth
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Posted June 19, 2026
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Commute Local Area
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Job Description


Job Description:
  • Regulatory Affairs Specialist with working knowledge of FDA, and CE marking requirements for IVD products. Client is currently transitioning from IVDD to IVDR (In Vitro Diagnostic Regulation).

  • The RAS is responsible for preparation & revision of IVD technical files when needed, updating labelling to comply with IVDR requirements, and tracking RA Regional notifications.
    • Responsibilities:
  • Support the IVDR project by revising the assigned technical files.

  • Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity.

  • Each technical file must include the latest version of the required technical reports, validations, test reports and other documents listed in the technical file table of contents which are an integral part of the tech...

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    📍 Location Details

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    City
    Fort Worth
    🗺️
    Country
    United States
    🚗
    Commute
    Local Area

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