About FiunEx: FiunEx is a highly specialized profit improvement operation consulting and Engineering service firm,which has a proven track record in flawless execution of projects in over 25 countries. We have developed a niche in Life Sciences sector driving majority of our revenues.
Through our unique engagement model and its success, we have experienced extremely tremendous growth in a short duration. We now have presence in US, Ireland, India and Thailand. For more details about the company, visit our website at www.fiunex.com.
Job Description
Regulatory Specialist – UDI
Position Overview
We are seeking a detail-oriented Regulatory Specialist – UDI to support the review, assessment, remediation, and implementation of medical device labeling and barcode requirements.
The role will be responsible for evaluating product labels and barcodes across all packaging levels to ensure compliance with UDI, GUDID, and GS1 requirements. The position will also support UDI assessments, label remediation activities, GUDID updates, change control actions,
and implementation of compliant labeling updates.
The ideal candidate will have solid attention to detail, excellent written communication skills, and a working knowledge of medical device labeling regulations, UDI requirements, GS1 barcode standards, and regulated change control processes.
Key Responsibilities
Review and assess product labels, packaging artwork, and barcodes across all packaging levels for UDI, GUDID, and GS1 compliance.
Perform detailed UDI assessments and complete required UDI checklists and compliance documentation.
Identify labeling and barcode gaps and support remediation activities to bring products into compliance.
Review UDI-related data and ensure consistency and accuracy across applicable labeling and regulatory records.
Support the preparation, review, and implementation of compliant labeling updates.
Execute assigned GUDID action items, including data review, updates, and corrections as required
📌 Regulatory Specialist-UDI (India)
🏢 FiunEx
📍 India