Description
UDI Project ManagerThere is a regulatory requirement that every medical device have a unique device identifier that allows for the identification of a device by human and machine readable format. The UDI is actual a system that is comprised of a UDI is a unique numeric or alphanumeric code.
My client a Medical Device Company in Southern Germany is currently looking for an experienced UDI Project Manager
UDI Role Description:
The Unique Device Identifier is a special system for the application of a unique identifier on Class I, II and III for immediate tracking and identification. Experience and deep knowledge of UDI (unique device identifier) and GUDID (Global Unique Identification Database) is required for this role.
Experience with the design and implementation of a UDI for medical device units
Candidate must have worked with a business unit such as supply chain, inventory, and regulatory, packaging or other pertinent business area
Candidate needs to have performed work activities associated with a business analyst such as performing interviews, creating requirements, linking the business requirements to the UDI design
Ideally the candidate has experience and knowledge of the medical device industry. Understanding of medical device distribution processes and functions
Must be knowledgeable of UDI regulatory timeline for implementation
Must have experience and knowledge of how to determine the feasibility of adding a UDI to a device and not affect its proper operation
Must have experience with and understand the GUDID (Global Unique Device Identifier Database) and the FDA requirements
Must be able to communicate between the business, IT and regulatory
Provide some level of recommendations on implementation of functionality
Experience with label UDI positioning and reading using DI and PI
Other Skills:
Expertise in ISO 13485, ISO 14971, FDA and EU regulations
Needs to understand how to read and work with a project plan
Needs to know how to build and work with workflow and dependency charts
Needs to be able to clearly articulate business requirements
Should you be interested in this or similar positions, please send me an email to
I am looking forward to hear from you!
Best Regards
Sabina Keel