Position: Unique Device Identifier (UDI) Analyst
Duration: Long term
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, 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
There 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 that consists of two parts:
• a device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device, and
• a production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
o the lot or batch number within which a device was manufactured;
o the serial number of a specific device;
o the expiration date of a specific device;
o the date a specific device was manufactured;
o the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
Thanks & Regards.....
Edison , New Jersey.
3 Ethel Rd,Suite # 304.
Direct: 609 357 4737 Ex : 458
Fax :(732) 626 6289
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