Aktuelle Jobs im Zusammenhang mit Medical Device UDI Specialist - Aalen, Baden-Württemberg - ZEISS Group
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Medical Device UDI Specialist
vor 2 Monaten
We are seeking a highly skilled and experienced professional to join our team as a Medical Device UDI Specialist. In this role, you will be responsible for ensuring the correct upload of UDI data to various databases, including the US and EU databases.
Key responsibilities include:
- Coordinating and executing database uploads to additional countries
- Assessing future UDI requirements and implementing identified requirements into our existing Quality Management System
- Ensuring UDI data collection and preparation for database upload
- Being the contact person for work packages within the currently running UDI Project
- Collaborating with stakeholders on SAP Add-ons
- Maintaining test plans for SAP Add-on testing
- Participating in bug fixing and ensuring Add-on functionalities are working correctly
- Supporting the creation and maintenance of relevant Standard Operating Procedures and Work Instructions
We are looking for a candidate with a strong background in medical technology, engineering, or a related field. The ideal candidate will have experience with UDI requirements, including those according to the EU MDR. Knowledge of additional country UDI requirements is an advantage.
Key qualifications include:
- Master's degree in medical technology, engineering, or equivalent
- Experience with UDI database(s) and upload
- Knowledge of quality management systems, including ISO 13485 and MDSAP
- Project management skills, including the application of relevant tools and methods
- Experience in process design and optimization
- Strong sense of quality and responsibility
- Structured and goal-oriented work style
- High level of motivation and willingness to take on responsibility
- Agile mindset and openness to new working methods
- Confident appearance, teamwork, and communication skills
We offer a dynamic and challenging work environment, with opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.
