Regulatory Affairs Specialist
Katalyst HealthCares & Life Sciences
Regulatory Affairs Specialist
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.
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 technical file. Each assigned technical file must be completed within a pre-defined timeline. Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and keep the project manager informed on the progress of the work. Support the IVDR labelling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan. Update the labeling conversion tracking log based on the monthly manufacturing schedule, the product fill dates, the associated product lot numbers and change requests numbers. As needed, update labeling specifications to meet the IVDR requirements. Support the tasks to un-CE Mark selected products and track the work until the final labeling reflects the desired changes based on the labeling specification document. Other miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator when specific product lots need to be restricted to prevent distribution of the product in specific areas of the world.
Requires a bachelor's degree in biochemistry, biology, medical technology or related fields. 2-5 years of experience in RA, and/or QA, R&D, Manufacturing or Project Management in the IVD industry. Knowledge of FDA, and CE marking requirements for IVD products.
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