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.

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 strong 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.
- Support and execute assigned change control activities related to labeling and UDI updates.
- Ensure required regulatory and compliance documentation is complete, accurate, and maintained appropriately.
- Coordinate with cross-functional teams to obtain required product, labeling, and packaging information.
- Work closely with QA, R&D;, Sourcing, Operations, and Suppliers to resolve labeling and compliance issues.




- Track assigned actions, milestones, and deliverables and provide timely updates on progress.
- Identify potential compliance gaps, inconsistencies, or data issues and escalate them appropriately.
- Maintain accurate records of assessments, decisions, updates, and supporting documentation.
- Provide weekly status updates on assigned activities, open actions, risks, and completed deliverables.
- Support continuous improvement of UDI and labeling compliance processes.

Required Qualifications & Experience

- Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Pharmacy, Medical Technology, or a related discipline .
- Experience in regulatory affairs, medical device labeling, UDI, quality, or a related regulated environment .
- Strong attention to detail and demonstrated ability to identify discrepancies in labels, barcodes, and regulatory data.
- Experience reviewing and documenting compliance requirements.
- Excellent written and verbal communication skills.
- Strong organizational skills with the ability to manage multiple activities and deadlines.
- Ability to work effectively with cross-functional teams and external suppliers.

Technical Skills

- Strong working knowledge of Microsoft Excel and Microsoft Word .
- Experience with Adobe Acrobat / Adobe Sign or similar document review and signature tools.
- Experience working with GUDID or similar regulatory databases.
- Familiarity with ComplianceQuest or other quality management systems.
- Strong ability to review, compare, and validate detailed labeling and regulatory information.

Preferred Domain Knowledge

- Unique Device Identification (UDI) requirements
- GUDID requirements and processes
- GS1 barcode standards and requirements
- Medical device labeling regulations
- Labeling and packaging hierarchy
- Barcode and product identification requirements
- Regulatory change control processes
- Label remediation and implementation processes
- Medical device quality and compliance processes

Key Competencies





- Regulatory and compliance assessment
- Exceptional attention to detail
- Analytical and problem-solving skills
- Documentation accuracy
- Regulatory data management
- Cross-functional collaboration
- Strong written communication
- Organization and prioritization
- Ability to identify and resolve compliance gaps
- Accountability and follow-through
- Ability to work independently while coordinating effectively with multiple stakeholders

Key Performance Indicators Success in this role will be measured through:

- Accuracy of UDI, labeling, and barcode compliance assessments
- Timely completion of UDI checklists and assigned assessments
- On-time completion of labeling remediation activities
- Timely and accurate completion of GUDID updates and action items
- Timely execution and closure of assigned change control activities
- Accuracy and completeness of regulatory documentation
- Adherence to project milestones and implementation timelines
- Effective identification and resolution/escalation of compliance gaps
- Timely and accurate weekly status reporting

Key Stakeholder Interfaces The role will work closely with:

- Quality Assurance (QA)
- Research & Development (R&D;)
- Sourcing / Procurement
- Operations
- Regulatory / Compliance
- Suppliers / External Partners
- Project Management

Reporting & Communication

- Provide weekly updates on progress, completed assessments, open actions, issues, and upcoming activities.
- Communicate labeling and UDI compliance findings clearly to relevant stakeholders.
- Escalate significant compliance gaps, data discrepancies, or implementation risks in a timely manner.
- Maintain transparent and accurate documentation supporting regulatory decisions and labeling changes.

Ideal Candidate Profile The ideal candidate is a detail-oriented regulatory professional with hands-on experience in UDI and medical device labeling compliance . They should be comfortable reviewing detailed labels and barcodes, identifying compliance gaps, working with GUDID data, completing regulatory documentation, and coordinating remediation activities across multiple functions.

A strong candidate will combine regulatory knowledge with practical execution skills , ensuring that compliant labeling changes are accurately assessed, documented, implemented, and maintained.

📌 Regulatory Specialist-UDI (Pune)
🏢 FiunEx
📍 Pune