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Medical Device UDI Specialist

vor 1 Monat


Aalen, Baden-Württemberg, Deutschland ZEISS Group Vollzeit
Your Role

We are seeking a highly skilled and experienced professional to join our team as a Medical Device UDI Specialist. As a key member of our Quality Management System team, you will be responsible for ensuring compliance with regulatory requirements and implementing effective processes to support our business.

Key Responsibilities
  • Coordinate and execute UDI database uploads to various countries, including the US, EU, and South Korea.
  • Assess and implement future UDI requirements into our Quality Management System.
  • Collect and prepare UDI data for database uploads.
  • Collaborate with stakeholders on SAP Add-ons and ensure compliance with regulatory requirements.
  • Maintain test plans for SAP Add-on testing and participate in bug fixing.
  • Ensure all functionalities of Add-ons are working correctly.
  • Support the creation and maintenance of Standard Operating Procedures and Work Instructions.
  • Develop and maintain label specifications, technical drawings, and reports.
Your Profile

We are looking for a highly motivated and experienced professional with a strong background in medical technology, quality management, and regulatory compliance. The ideal candidate will have:

  • A master's degree in medical technology, engineering, or a related field.
  • Knowledge of UDI requirements and regulations, including EU MDR 2017/745.
  • Experience with UDI databases, including upload and data maintenance.
  • Strong project management skills and experience with quality management systems.
  • Excellent communication and teamwork skills.
  • Proficiency in MS Office products and strong analytical skills.
About ZEISS Group

ZEISS is a leading technology company that designs, develops, and manufactures innovative solutions for various industries, including medical technology. We are committed to delivering high-quality products and services that meet the needs of our customers and stakeholders.