Regulatory Affairs Specialist

About FiunEx :

FiunEx is a growing operations consulting and engineering services firm committed to delivering measurable business impact through profit improvement and operational excellence. With successful project delivery across more than 25 countries, FiunEx has built a strong reputation for excellence and a distinctive presence in the Life Sciences sector.

Driven by a collaborative delivery model and a strong commitment to client success, FiunEx offers professionals the opportunity to contribute to meaningful, high-impact work in a dynamic global environment. The company has an international presence across the United States, Ireland, India, and Thailand. For more information, please visit .

Regulatory Affairs Specialist – UDI Compliance

Role Overview

As a Regulatory Affairs Specialist – UDI Compliance , you will support the development, implementation, and ongoing maintenance of UDI compliance strategies to ensure medical devices meet applicable global identification and traceability requirements. This includes interpreting and applying relevant regulatory frameworks, including the U.S. FDA Unique Device Identification requirements and associated GUDID obligations, as well as applicable EU MDR/IVDR UDI and device registration requirements. The role involves maintaining UDI data accuracy across labelling, documentation, and regulatory systems; supporting submissions and updates to applicable regulatory databases; and providing practical regulatory guidance throughout the product lifecycle.

In this role, you will work closely with cross-functional teams to support compliant UDI implementation, labelling assessment, change control, and regulatory data governance activities. You will help ensure that device identification information remains accurate, consistent, and inspection-ready across product labels, technical documentation, and controlled database records, while contributing to timely and compliant regulatory deliverables for both client and internal requirements.

Key Responsibilities

Global UDI Strategy & Regulatory Compliance

• Support the development and execution of UDI compliance strategies aligned with applicable global regulatory requirements, including U.S. FDA UDI requirements under 21 CFR Part 801 and Part 830, EU MDR/IVDR UDI obligations, and other evolving jurisdiction-specific expectations.
• Apply regulatory requirements related to device identification, traceability, labelling, and database submissions to ensure products remain compliant throughout the lifecycle.
• Monitor regulatory updates, guidance documents, and industry standards, including relevant FDA guidance, MDCG guidance, and internationally harmonized UDI principles, and communicate potential business impacts to internal stakeholders.
• Track evolving requirements in additional markets, including the United Kingdom and Canada, and support readiness activities for future UDI-related implementation needs.

UDI Data Management & Governance

• Create, maintain, and validate master UDI records for medical devices, including UDI-DI, UDI-PI elements, packaging hierarchy, and other required product attributes such as intended use, model/version information, nomenclature codes, and risk classification.
• Support the management of Basic UDI-DI records for applicable EU MDR/IVDR device groups to ensure proper linkage between device families, technical documentation, certificates, and database records.
• Ensure consistency, accuracy, and traceability of UDI data across labelling, controlled documentation, regulatory records, and enterprise systems such as ERP, PLM, or regulatory information management tools.
• Contribute to data governance, validation, and review processes designed to maintain UDI data integrity and inspection readiness.

Regulatory Database Submissions & Record Maintenance

• Prepare, submit, and maintain UDI-related records in applicable regulatory databases, including FDA GUDID and, where applicable, EUDAMED UDI/Device modules, ensuring all required attributes are complete, accurate, and current.
• Support updates to regulatory database records associated with product changes, packaging updates, discontinuations, or other lifecycle events requiring record maintenance.
• Assist with UDI data submissions or readiness activities for other regional registries and public data repositories as regulatory requirements evolve.
• Maintain supporting documentation and evidence for submitted records to ensure traceability, auditability, and regulatory consistency.

Labelling, Artwork Review & UDI Verification

• Review and assess device labels, packaging artwork, and instructions for use to confirm that UDI carriers, human-readable text, and related labelling elements comply with applicable regulatory and internal requirements.
• Verify alignment between label content, barcode data, and approved master UDI records to ensure consistency across labelling and database submissions.
• Support barcode verification and readability checks in accordance with recognized industry standards and internal controls.
• Ensure labelling is updated in a timely manner when product or packaging changes affect UDI assignment, presentation, or traceability requirements.

Change Control, Product Lifecycle & Cross-Functional Collaboration

• Evaluate product changes, new product introductions, and lifecycle events to determine whether revised UDI-DI, Basic UDI-DI, labelling, or database updates are required.
• Integrate UDI requirements into change control, product transfer, launch, discontinuation, and traceability-related activities to support compliant lifecycle management.
• Collaborate with Quality, Engineering, Manufacturing, Supply Chain, IT, and Regulatory teams to obtain required inputs, support system alignment, and enable effective UDI implementation across functions.
• Provide UDI-related regulatory input for technical documentation, submissions, certifications, and commercial or operational readiness activities, as needed.
• Support audit and inspection readiness by preparing traceability evidence, database records, label examples, procedures, and other documentation demonstrating UDI compliance.
• Contribute to continuous improvement initiatives through regulatory intelligence, gap assessments, process enhancements, and training support to strengthen UDI compliance capabilities across the organization.

Required Qualifications

Education

• Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Engineering, or a related scientific discipline.
• Master’s degree or advanced regulatory certification, such as RAC, is an advantage.

Experience

• 3–6 years of experience in medical device regulatory affairs, including hands-on exposure to UDI compliance activities, regulatory submissions, and device labelling support.
• For more advanced profiles, experience leading UDI-related projects, global device registration activities, or cross-functional regulatory implementation initiatives is strongly valued.
• Demonstrated experience with FDA GUDID submissions, EU MDR/IVDR registration requirements, and medical device labelling compliance is strongly preferred.
• Working knowledge of change control, document control, product lifecycle support, and audit or inspection readiness activities within a regulated environment is preferred.

Technical Knowledge

• Good understanding of applicable medical device regulatory frameworks, including U.S. FDA UDI requirements under 21 CFR Part 801 and Part 830, as well as EU MDR/IVDR UDI and device registration requirements.
• Awareness of evolving regional expectations, including U.K. regulatory direction for device registration and UDI implementation, is advantageous.
• Familiarity with quality and labelling standards relevant to UDI and medical device information, including ISO 13485, ISO 15223-1, and ISO 20417.
• Familiarity with recognized UDI issuing agencies and coding systems, including GS1, HIBCC, and ICCBBA.
• Experience working with regulatory databases and systems such as GUDID, EUDAMED, and enterprise tools such as RIM, ERP, PLM, or related data management platforms is preferred.
• Strong proficiency in Microsoft Excel and other core Microsoft Office applications is expected; experience with data analysis, structured data review, or system-based record management is an advantage.

Preferred Skills

• Experience supporting global device registration strategies across key markets, including the U.S., EU, and other international jurisdictions.
• Strong understanding of labelling content review, artwork verification, and UDI-related label compliance.
• Experience with change control, risk-based regulatory assessment, and lifecycle regulatory support.
• Project coordination skills, with the ability to manage multiple priorities and contribute effectively to cross-functional initiatives.
• Exposure to data automation, bulk upload tools, system integrations, or structured regulatory data exchange processes is a plus.