Regulatory Affairs Specialist

For more information, please visit www.fiunex.com.\n\nRegulatory Affairs Specialist – UDI Compliance\nRole Overview\nAs 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.\nIn 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.\n\nKey Responsibilities\nGlobal UDI Strategy & Regulatory Compliance\nSupport 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.\nApply regulatory requirements related to device identification, traceability, labelling, and database submissions to ensure products remain compliant throughout the lifecycle.\nMonitor 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.\nTrack evolving requirements in additional markets, including the United Kingdom and Canada, and support readiness activities for future UDI-related implementation needs.\n\nUDI Data Management & Governance\nCreate, 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.\nSupport 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.\nEnsure 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.\nContribute to data governance, validation, and review processes designed to maintain UDI data integrity and inspection readiness.\n\nRegulatory Database Submissions & Record Maintenance\nPrepare, 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.\nSupport updates to regulatory database records associated with product changes, packaging updates, discontinuations, or other lifecycle events requiring record maintenance.\nAssist with UDI data submissions or readiness activities for other regional registries and public data repositories as regulatory requirements evolve.\nMaintain supporting documentation and evidence for submitted records to ensure traceability, auditability, and regulatory consistency.\n\nLabelling, Artwork Review & UDI Verification\nReview 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.\nVerify alignment between label content, barcode data, and approved master UDI records to ensure consistency across labelling and database submissions.\nSupport barcode verification and readability checks in accordance with recognized industry standards and internal controls.\nEnsure labelling is updated in a timely manner when product or packaging changes affect UDI assignment, presentation, or traceability requirements.\n\nChange Control, Product Lifecycle & Cross-Functional Collaboration\nEvaluate product changes, new product introductions, and lifecycle events to determine whether revised UDI-DI, Basic UDI-DI, labelling, or database updates are required.\nIntegrate UDI requirements into change control, product transfer, launch, discontinuation, and traceability-related activities to support compliant lifecycle management.\nCollaborate with Quality, Engineering, Manufacturing, Supply Chain, IT, and Regulatory teams to obtain required inputs, support system alignment, and enable effective UDI implementation across functions.\nProvide UDI-related regulatory input for technical documentation, submissions, certifications, and commercial or operational readiness activities, as needed.\nSupport audit and inspection readiness by preparing traceability evidence, database records, label examples, procedures, and other documentation demonstrating UDI compliance.\nContribute to continuous improvement initiatives through regulatory intelligence, gap assessments, process enhancements, and training support to strengthen UDI compliance capabilities across the organization.\n\nRequired Qualifications\nEducation\nBachelor’s degree in Regulatory Affairs, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Engineering, or a related scientific discipline.\nMaster’s degree or advanced regulatory certification, such as RAC, is an advantage.\n\nExperience\n3–6 years of experience in medical device regulatory affairs, including hands-on exposure to UDI compliance activities, regulatory submissions, and device labelling support.\nFor more advanced profiles, experience leading UDI-related projects, global device registration activities, or cross-functional regulatory implementation initiatives is strongly valued.\nDemonstrated experience with FDA GUDID submissions, EU MDR/IVDR registration requirements, and medical device labelling compliance is strongly preferred.\nWorking knowledge of change control, document control, product lifecycle support, and audit or inspection readiness activities within a regulated environment is preferred.\n\nTechnical Knowledge\nGood 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.\nAwareness of evolving regional expectations, including U.K. regulatory direction for device registration and UDI implementation, is advantageous.\nFamiliarity with quality and labelling standards relevant to UDI and medical device information, including ISO 13485, ISO 15223-1, and ISO 20417.\nFamiliarity with recognized UDI issuing agencies and coding systems, including GS1, HIBCC, and ICCBBA.\nExperience 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.\nStrong 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.\n\nPreferred Skills\nExperience supporting global device registration strategies across key markets, including the U.S., EU, and other international jurisdictions.\nStrong understanding of labelling content review, artwork verification, and UDI-related label compliance.\nExperience with change control, risk-based regulatory assessment, and lifecycle regulatory support.\nProject coordination skills, with the ability to manage multiple priorities and contribute effectively to cross-functional initiatives.\nExposure to data automation, bulk upload tools, system integrations, or structured regulatory data exchange processes is a plus.