Aktuelle Jobs im Zusammenhang mit Senior UDI Specialist - Aalen, Baden-Württemberg - ZEISS

We are seeking a highly skilled and experienced Senior UDI Specialist to join our team at ZEISS. As a key member of our Quality Management team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.

• Manage the correct collection, preparation, and upload of our UDI database to various regions, including the U.S., South Korea, and EU.
• Assess future UDI requirements and implement identified requirements into our existing Quality Management System.
• Provide and support work packages within the currently running UDI Project.
• Take responsibility for the lifecycle of UDI/label activities, including establishing print validation, correct UDI integration within the product change process, time management, data upload, and preparation of documentations and rollouts.
• Operate stakeholder management with internal and external partners for our collaboration on SAP Add-ons (currently U.S. and EU).
• Maintain the test plan for SAP Add-in collaboration with Corporate IT and Master Data Management, correct possible bugs, and ensure a correct upload process proactively.
• Support the creation and maintenance of relevant standard operating procedures and work instructions.
• Take care of specifications, technical drawings, and reports for different labels.

• A master's degree in medical technology/engineering or equivalent.
• Knowledge of UDI requirements according to (EU) 2017/745 MDR and advantageous experience with further country UDI requirements.
• Existing empirical values with UDI databases, including upload and data maintenance.
• Project management skills, including the application of relevant tools and methods.
• Experience in the design and optimization of processes.
• Beneficial professional experience in medical technology (including but not limited to UDI and label requirements) and quality management (ISO 13485, MDSAP).
• Professional competence in the use of MS Office products.
• A structured, independent, and implementation-oriented way of working with good teamwork and communication skills.
• A high level of motivation, as well as the willingness to take on responsibility and familiarize with new topics.
• Very good English writing and speaking skills, German as a plus.