What are the responsibilities and job description for the Regulatory Affairs Specialist position at TekOne IT Services Pvt. Ltd. ?
Technical File Revisions: Support the IVDR project by revising technical files using the latest templates. Ensure each file clearly presents the product, its characteristics, and expected performance to demonstrate evidence of conformity. Include the latest versions of required technical reports, validations, test reports, and other relevant documents. Complete assigned technical files within a predefined timeline and attend weekly meetings to address issues or questions. Keep the project manager informed on progress. IVDR Labeling Conversion: Support the IVDR labeling conversion project, including weekly meetings and cross-functional collaboration. Update the labeling conversion tracking log based on the monthly manufacturing schedule, product fill dates, lot numbers, and change request numbers. Update labeling specifications to ensure compliance with IVDR requirements. Un-CE Marking: Assist in un-CE marking selected products and track work until final labeling reflects changes. Ensure that updates align with the labeling specification document. Regulatory Notifications: Update the technical file tracking log and track regional regulatory notifications of labeling changes. Notify the RA SAP restriction coordinator when product lots need to be restricted to prevent distribution in specific regions. Miscellaneous Tasks: Complete other activities related to regulatory compliance as needed to support the project. Qualifications Experience: Must have working knowledge of FDA and CE marking requirements for IVD (In Vitro Diagnostic) products. Experience with transitioning products from IVDD to IVDR is highly preferred. Strong technical writing and documentation skills. Education: Bachelor’s degree in a related field (e.g., Regulatory Affairs, Biomedical Engineering, or Life Sciences). Technical Skills: Experience with technical file preparation and revision. Knowledge of labeling specifications and regulatory conversion processes. Familiarity with IVDR compliance and labeling requirements. Strong project management and organizational skills. Communication Skills: Ability to work cross-functionally and attend multiple weekly meetings to track progress and address issues. Strong attention to detail in managing technical documentation and timelines.
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