Katalyst CRO
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Responsibilities
Revise assigned technical files for IVDR compliance, ensuring each file is updated with the latest template, technical reports, validations, test reports, and other required documents.
Ensure each technical file is completed within the defined timeline and attend multiple weekly meetings to address issues and update the project manager on progress.
Support the IVDR labeling conversion project by maintaining the labeling conversion tracking log, updating it based on the monthly manufacturing schedule, product fill dates, lot numbers, and change request numbers.
Update labeling specifications to meet IVDR requirements as needed.
Manage the un‑CE marking of selected products, tracking progress until final labeling meets specification requirements.
Perform miscellaneous activities, including: updating the technical file tracking log; notifying and tracking RA Regional notifications of labeling changes; and notifying the RA SAP restriction coordinator of product lot restrictions to prevent distribution in designated regions.
Requirements
Experience with the transition from IVDD to IVDR (In Vitro Diagnostic Regulation).
Conducting preparation and revision of IVD technical files as required.
Updating labeling to meet IVDR requirements and tracking RA Regional notifications.
Bachelor’s degree in biochemistry, biology, medical technology or a related field.
Minimum 3 years of experience in Regulatory Affairs, QA, R&D, Manufacturing or Project Management within the IVD industry.
Knowledge of FDA and CE marking requirements for IVD products.
Seniority level Associate
Employment type Contract
Job function
Legal
Pharmaceutical Manufacturing
Location & Salary Dallas‑Fort Worth Metroplex – $45.00 – $48.00 per hour (posted 2 days ago)
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Responsibilities
Revise assigned technical files for IVDR compliance, ensuring each file is updated with the latest template, technical reports, validations, test reports, and other required documents.
Ensure each technical file is completed within the defined timeline and attend multiple weekly meetings to address issues and update the project manager on progress.
Support the IVDR labeling conversion project by maintaining the labeling conversion tracking log, updating it based on the monthly manufacturing schedule, product fill dates, lot numbers, and change request numbers.
Update labeling specifications to meet IVDR requirements as needed.
Manage the un‑CE marking of selected products, tracking progress until final labeling meets specification requirements.
Perform miscellaneous activities, including: updating the technical file tracking log; notifying and tracking RA Regional notifications of labeling changes; and notifying the RA SAP restriction coordinator of product lot restrictions to prevent distribution in designated regions.
Requirements
Experience with the transition from IVDD to IVDR (In Vitro Diagnostic Regulation).
Conducting preparation and revision of IVD technical files as required.
Updating labeling to meet IVDR requirements and tracking RA Regional notifications.
Bachelor’s degree in biochemistry, biology, medical technology or a related field.
Minimum 3 years of experience in Regulatory Affairs, QA, R&D, Manufacturing or Project Management within the IVD industry.
Knowledge of FDA and CE marking requirements for IVD products.
Seniority level Associate
Employment type Contract
Job function
Legal
Pharmaceutical Manufacturing
Location & Salary Dallas‑Fort Worth Metroplex – $45.00 – $48.00 per hour (posted 2 days ago)
#J-18808-Ljbffr