Regulatory Labeling & UDI Specialist

Project overview

We are looking for an experienced Regulatory Labeling & UDI Specialist for a project in medical technology. You will be involved in the creation, review, updating, and versioning of product labels, packaging information, and regulatory product information.

Your tasks include implementing regulatory requirements for labeling and product information, especially in the context of EU MDR and IVDR. You will process and maintain UDI-relevant information such as UDI-DI and UDI-PI, as well as associated master product data. Managing product and regulatory data in relevant systems is also part of your responsibilities, as is coordinating label and artwork changes, including review, release, and documentation processes.

Furthermore, you will create and update Instructions for Use (IFU) and support the implementation of digital instructions for use. You will implement changes within defined change management processes and document them. Coordination with relevant interfaces from various departments is an essential part of the role.

We expect several years of project experience in the labeling, regulatory, or product information environment of medical technology. Sound knowledge of regulatory requirements for Medical Devices and In-vitro-Diagnostics is required. Practical experience with UDI systems, the creation and management of labels and artwork, as well as with IFU/eIFU is assumed. Knowledge of relevant management systems and experience with structured processes in regulated environments are necessary. Independent, structured work style and experience in interdisciplinary collaboration complete the profile.

The project is planned for 3-6 months with an option for extension and will be staffed full-time.

Project details

• Start: 23.11.2026 / kurzfristig nach Absprache
• Duration: 3-6 Monate
• Remote: onsite
• Location: Mannheim, DE
• Languages: German