Job Description :

Greeting from KrishAnsh!!

We are looking for a candidate for the position of Labeling Lead.

Position: Labeling Lead

Duration: Long Term

Location: Cincinnati, OH

Job Description:

?Labeling Lead with 8+ years of EUMDR experience in Medical device

Co-ordinate with Subject Matter Experts for EU-MDR SME/s & labeling stakeholders for requirements gathering, analyzing and lead the review sessions

? Ensure smooth coordination of project activities between Buyer and SME team.

? Identify labels to be changed and plan execution of changes to affected parts

? Experience in FDA regulations and understand the EU-MDR regulations.

? Understand the terminology with in the pharma and medical device industry

? Analyze and Execute graphics changes in Labels per Change Order (CO) requirements as per EU-MDR requirement

? Complete the change assessment form & close action task in CO.

? Requirement gathering for each label change. & in certain cases finalize verbiage for the proposed change.

? Redline generation for the Label changes.

? Conduct & sign off the design review and close design review task in CO.

? Sign off artwork CO

Client : KrishAnsh LLC