Katalyst CRO
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Regulatory Affairs Specialist
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Katalyst CRO .
Job Description Regulatory Affairs Specialist II 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 labeling 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 clearly present the product, its characteristics and its expected performance to fully understand the evidence of conformity. Each 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. Each assigned technical file must be completed within a pre-defined timeline. Must attend multiple weekly meetings intended to address issues or questions regarding the technical files and keep the project manager informed on progress.
Support the IVDR labeling conversion project that 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, product fill dates, associated product lot numbers and change request 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.
Requirements
Requires a bachelor's degree in biochemistry, biology, medical technology or related fields.
3–5 years of experience in RA, QA, R&D, manufacturing or project management in the IVD industry.
MUST HAVE IVD (In‑vitro Diagnostics) experience.
Knowledge of FDA and CE marking requirements for IVD products.
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Regulatory Affairs Specialist
role at
Katalyst CRO .
Job Description Regulatory Affairs Specialist II 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 labeling 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 clearly present the product, its characteristics and its expected performance to fully understand the evidence of conformity. Each 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. Each assigned technical file must be completed within a pre-defined timeline. Must attend multiple weekly meetings intended to address issues or questions regarding the technical files and keep the project manager informed on progress.
Support the IVDR labeling conversion project that 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, product fill dates, associated product lot numbers and change request 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.
Requirements
Requires a bachelor's degree in biochemistry, biology, medical technology or related fields.
3–5 years of experience in RA, QA, R&D, manufacturing or project management in the IVD industry.
MUST HAVE IVD (In‑vitro Diagnostics) experience.
Knowledge of FDA and CE marking requirements for IVD products.
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