About Fiun Ex:
Fiun Ex 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, Fiun Ex 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, Fiun Ex offers professionals the opportunity to contribute to meaningful, high-impact work in a agile 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 requ

📌 Regulatory affairs specialist (Pune)
🏢 FiunEx
📍 Pune