Medical Device Labeling Specialist


Science and Research

Advert ID



Hawthorn Woods

Job Type




Salary Range

Up to USD0.00 per year

No. of Openings


Branch Information

Chicago Engineering - (USA) 525 West Monroe Street Suite 1500 IL Chicago , IL 60661



Job Description

Do you want to be part of a team where you'll do important work and your work will have a real-world impact? Do you want to be supported in achieving your career goals? Then we have an opportunity for you!

As a Medical Device Labeling Specialist you will lead small scale medical device labeling projects to support R&D initiatives, quality/compliance initiatives, and market expansion.

Primary Responsibilities:

* Lead small scale medical device labeling projects to support R&D initiatives, quality / compliance initiatives, and market expansion.

* Participate in cross-functional team meetings to define label requirements.

* Support Fresenius Kabi production facilities with implementation of labeling changes.

* Process design change control documentation in the electronic change management system, and process label change orders in the electronic document management system for updates to labeling and related specifications.

* Revise product specifications and Bill of Materials to implement label changes.

* Support and lead label changes as required by the new European MDR Regulation, complete Change Control documentation and work with the manufacturing facilities to implement the new labels.


* Detail-oriented, process-oriented thinker with experience on cross-functional teams.

* Bachelor's degree required; concentration in engineering or packaging technology preferred.

* Medical device background and/or experience with electronic document management systems and/or label/material specifications preferred.

* Proficiency with standard Microsoft desktop applications and Adobe Acrobat required.

* Bar code / UDI experience is helpful.

* Knowledge of country-specific regulatory requirements not required.

Mon - Friday 8am to 5pm CST - flexible 8 hour shift