Regulatory Labeling & UDI Specialist

Project overview

We are looking for a Regulatory Labeling & UDI Specialist

• Creation, review, updating, and versioning of product labels, packaging information, and associated regulatory product information
• Implementation of regulatory requirements for labeling and product information, especially in the context of EU MDR and IVDR
• Processing and maintenance of UDI-relevant information, particularly UDI-DI, UDI-PI, and associated master product data
• Maintenance and management of relevant product and regulatory data in Polarion
• Coordination of label and artwork changes, including review, approval, and documentation processes
• Creation, updating, and management of Instructions for Use (IFU) and support for the implementation and maintenance of eIFU
• Execution and documentation of changes within defined change management processes
• Coordination with relevant interfaces from Regulatory Affairs, Quality, Product Management, Engineering, and other project-related departments
• Several years of project experience in the labeling, regulatory, or product information environment of medical technology
• Sound knowledge of regulatory requirements for Medical Devices or In-vitro Diagnostics, especially EU MDR and/or IVDR
• Practical experience with UDI, UDI-DI, UDI-PI, and regulatorily relevant master product data
• Experience in the creation, review, approval, and versioning of labels, artwork, and packaging information
• Experience with IFU/eIFU and the management of digital instructions for use
• Knowledge of Polarion or comparable systems for requirements, documentation, or product data management
• Experience with structured change, review, and approval processes in a regulated environment
• Independent, structured way of working and experience in collaborating with different departments
• Start: short notice / by arrangement
• Duration: 3-6 months +, with option for extension
• Workload: Full-time
• Location: Remote / by arrangement
• Industry: Medical Technology / Medical Devices

Project details

• Start: flexible
• Location: Mannheim, Baden-Württemberg, DE
• Languages: German