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This position is responsible for directing the activities related to the development and implementation of MDR compliant labeling for products sold in the European Union.  This position will be responsible for managing projects within the sustaining engineering / shared services group within the Urology and Critical Care Business. The position will be required to interface with all project stakeholders at UCC, including stakeholders at multiple sites (e.g. regulatory affairs, quality assurance, labeling, manufacturing, sourcing, etc.), to develop the appropriate timelines and ensure the assembled teams can successfully execute the assigned projects. Knowledge of European Medical Device Regulations (MDR) for Medical Devices is a plus




  • Act as the team leader for Labeling and/or Packaging Projects within UCC.

  • Responsible for team meetings (e.g., face-to-face, teleconference, and/or webinars) and generation of meeting minutes.

  • Responsible for design reviews as needed.

  • Responsible for communication of team objectives, charter, milestones and progress

  • Owner of project status updates for Projects.

  • Preparation of reports and presentations.

  • Develop and track project budgets.

  • Work with Finance to prepare project financial models, budget tracking spreadsheets and reports.

  • Develop, assist in developing, and/or execute protocols and evaluations of products affected by design changes.

  • Partner in continuous improvement of Packaging and Labeling Processes and Procedures.

  • Help to identify stakeholders.

  • Work with all stakeholders to build consensus on areas for improvement.

  • Author new or modified procedures to address opportunities for improvement.

  • Manage the research, scoping and execution of the electronic management of workflow.

  • Ensure products are packaged and labeled in accordance with Corporate and Division product development policies. Travel based on project needs (e.g. to UCC facilities, conferences, etc.).

  • Travel based on project needs (e.g. to UCC facilities, conferences, etc.).




To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Demonstrated project management skills or certifications.

  • Knowledge and understanding of FDA and ISO medical device development regulations; especially as they pertain to design control and product development.

  • Knowledge of corporate, division, and standard operating procedures, as they relate to Product Labeling and Sustaining Engineering.

  • Knowledge of project-based product development and ability to work as a project leader.

  • Excellent communication skills (written and verbal) with ability to influence.

  • Proficient in the use of a personal computer with experience in Microsoft Word, Excel, Power Point, Microsoft Project, network systems (electronic mail) and Internet applications.




Education and/or Experience:

  • Minimum undergraduate degree (BS) in a technical or business management area and a minimum of 3 years’ experience in Regulated Industry.

  • Experience with project management systems (e.g. Microsoft Project) is highly desired.

  • Prior knowledge of medical device packaging, labeling, labeling management software, UDI and MDR highly desired.

Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!

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