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Entry-Level UDI Specialist
vor 3 Monaten
Step into a rewarding career where you can challenge yourself and push the boundaries of innovation. At ZEISS, our team members are dedicated to achieving excellence every day, contributing to our legacy of groundbreaking advancements.
In a contemporary and dynamic environment that fosters professional growth, ZEISS employees thrive in a culture of expertise and collaboration. Our unique ownership structure, guided by the long-term vision of the Carl Zeiss Foundation, aims to bridge the gap between science and society for a better future.
Join us and make a difference
Diversity and Inclusion are core values at ZEISS. We welcome applications from individuals of all backgrounds, regardless of gender, nationality, ethnicity, religion, disability, age, sexual orientation, or identity.
Key Responsibilities:
- Ensure accurate collection, preparation, and submission of our UDI database for various regions, including the U.S., South Korea, and the EU.
- Evaluate upcoming UDI requirements and integrate them into our established Quality Management System.
- Support and manage work packages within the ongoing UDI Project.
- Oversee the lifecycle of UDI and labeling activities, including print validation, UDI integration in product changes, time management, data uploads, and documentation preparation.
- Facilitate stakeholder engagement with internal and external partners regarding our SAP Add-ons.
- Maintain the testing plan for SAP Add-ins in collaboration with Corporate IT and Master Data Management, proactively addressing bugs and ensuring a smooth upload process.
- Assist in the development and maintenance of standard operating procedures and work instructions.
- Manage specifications, technical drawings, and reports for various labels.
Qualifications:
- A master's degree in medical technology, engineering, or a related field.
- Familiarity with UDI regulations as per (EU) 2017/745 MDR, with additional knowledge of other country-specific UDI requirements being advantageous.
- Experience with UDI databases, including data uploads and maintenance.
- Project management expertise, utilizing relevant tools and methodologies.
- Background in process design and optimization.
- Professional experience in medical technology, particularly in UDI and labeling requirements, as well as quality management (ISO 13485, MDSAP).
- Proficient in MS Office applications.
- A structured, independent, and results-oriented work style, complemented by strong teamwork and communication skills.
- A high level of motivation, a willingness to take on responsibilities, and an eagerness to learn new concepts.
- Excellent English communication skills, both written and spoken; proficiency in German is a plus.
