Hi  Folks,

Hope you are doing great today!!! Please find the following Direct Client
requirement and revert me back with suitable profiles.
Revert me back on this mail or reach me at 732 982 5999.

Position: *Unique Device Identifier (UDI) Analyst*
Location: FL
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

About UDI:
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.....

Rocky
Sr.Technical It Recruiter
ro...@centraprise.com
Centraprise Corp
Edison , New Jersey.
3 Ethel Rd,Suite # 304.
Direct: (732) 982 5999  Ex : 452
Fax :(732) 626 6289
Minority Owned (MBE) Certified

-- 
You received this message because you are subscribed to the Google Groups "Open 
Source Erp & Crm" group.
To unsubscribe from this group and stop receiving emails from it, send an email 
to open-source-erp-crm+unsubscr...@googlegroups.com.
To post to this group, send email to open-source-erp-crm@googlegroups.com.
Visit this group at https://groups.google.com/group/open-source-erp-crm.
For more options, visit https://groups.google.com/d/optout.

Reply via email to