Job Description

Who we want
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

The Label Design Specialist can be based out of the following Stryker locations: Mahwah NJ, Bloomington, MN or Memphis, TN.

What you will do

* Creation and maintenance of labelling (e.g. IFUs) in collaboration with R&D, RA and other stakeholders from different locations in accordance with relevant standards and regulatory requirements.
* Quality review of labelling documents, coordination of the review and approval process of labelling documents.
* Coordination of labelling translations in cooperation with the translation agency, including QA inspection and approval.
* Publication of labelling and collateral material on different repositories. Coordinating the print process of IFUs including blue line sample approval.
* Creation and maintenance (from draft to production release) of product labels and label templates in the dedicated systems, including coordination of updates under applicable change control process.
* Management cross-functional projects, regular reports and metrics.
* Process maintenance to keep high level of quality (e.g. NC/CAPA).

What you need

Basic Qualifications:

* Bachelors Degree required
* Minimum 2 years experience in graphic design, labelling, quality, regulatory affairs or experience working in a related role

Preferred Qualifications:

* Experience working in the Medical Device or Pharma Industry strongly preferred.
* Solid knowledge of Standards and Regulations regarding medical devices and labelling (US and EU).
* Excellent planning, organizational and project management skills.
* IT skills as well as expertise in documentation practices.
* Confident in using desktop publishing and graphic programs (e.g. Adobe InDesign, Photoshop, Illustrator) and quickly learner to use new softwares and systems/databases.
* Demonstrated experience in working with a label management system (e.g. SAP, Prisym ID, Robar by Innovatum, BarTender by Seagull Scientific).
* Excellent command of English is a must, any other EU language is a plus.
* Strong communication skills.
* Demonstrated ability of multi-tasking in a quick paced environment
* Organized, team-minded and detail and service oriented.