Katalyst Healthcares and Life Sciences
Regulatory Affairs Specialist II
Katalyst Healthcares and Life Sciences, Boston, Massachusetts, us, 02298
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.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 labeling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan.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.Requirements:
Bachelor's degree in biochemistry, biology, medical technology or related fields and 3+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 is a plusThorough knowledge of policies, practices and procedures related to RA.
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.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 labeling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan.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.Requirements:
Bachelor's degree in biochemistry, biology, medical technology or related fields and 3+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 is a plusThorough knowledge of policies, practices and procedures related to RA.