Required skills
- Medical Device Labeling
- UDI Implementation
- EU MDR
- IVDR
- Regulatory Affairs
- Product Information Management
- Instructions for Use (IFU)
- Change Management
- Polarion
- Quality Management
- Product Management
- Engineering
Languages: German
Job description
We are looking for a Regulatory Labeling & UDI Specialist for a full-time, remote position in the medical technology industry, starting soon with a contract duration of 3-6 months plus extension options.
Project overview
We are looking for a Regulatory Labeling & UDI Specialist
Job Description
Profile
- Start: immediately / by arrangement
- Duration: 3-6 months +, with option for extension
- Workload: Full-time
- Location: Remote / by arrangement
- Industry: Medical Technology / Medical Devices
- 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, especially 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) as well as 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-involved 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 as well as experience in collaborating with various departments
Project details
- Start: 2026-12
- Duration: 3 Monate
- Remote: hybrid
- Location: Mannheim, Deutschland, DE
- Languages: German
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