Expected Travel: None
Requisition ID: 4545
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
US COVID-19 Vaccination Requirements:
Teleflex is focused on the health and safety of our employees, their families, and our customers. Teleflex will comply with US government regulations regarding COVID-19 vaccination requirements for US workers. To ensure we are prepared for all applicable vaccination requirements, Teleflex is currently collecting vaccination status and accommodation requests from our US based employees.
Employees and new hires in sales or field-based roles that require vendor credentials to access to medical facilities as an essential function of the job may be required to obtain the COVID-19 vaccination based on customer/site requirements. This requirement is independent of Teleflex policy or any applicable US governmental regulations.
OEM - Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients' lives.
Create label design, approval, and printing of label content for the performance fibers business to support EU MDR requirements. Document change analysis for the processing and releasing of all document and labeling changes associated with MDR in the Teleflex Agile system. Assigns training to new documents as required.
• Develop and maintain Regulatory compliant labeling per EU MDR and internal procedure requirements.
• Maintain label database(s) and create new label templates as necessary.
• Work with appropriate cross-functional departments and external customers to design OEM label formats for new product development projects using the current approved standards; revise existing OEM label designs using the current approved label design standards; and develop label templates that are capable of interacting with label content databases to produce regulatory compliant label copy.
• Liaise between plant personnel and external customers to implement label changes and to ensure all changes are appropriately documented and controlled.
• Ensure that the label content review and approval process is comprehensive and consistently executed across all internal and external relevant functions within the OEM organization.
• Prepare labeling Document Change Order (DCO) packages, route for internal and external approval and oversee package until closure.
• Work with engineering to develop and obtain approval and release of label drawings.
• Work with the Sr. labeling specialist for support with translation and print vendors as required for label design projects.
• Responsible for initiating and overseeing the routing, releasing and closure of new or revised documents/labeling using the Agile document change order system.
• Work with all document owners to ensure each document change order package (DCO) is correctly structured per the Teleflex document change process.
• Work with the Quality System and Documentation Specialist for the timely assignment of training requirements for all new document releases.
• Provide support for EU MDR improvement projects as required.
Education / Experience Requirements
• Minimum of a High School diploma or GED is required. Associates's Degree in a Technical or Graphics field is desired.
• Minimum of three years of relevant experience, working with labeling & the document change/training processes.
• Experience in the medical device industry, Design and Development Process, and EU MDR preferred.
Specialized Skills / Other Requirements
• Strong computer skills including Microsoft Office, Word, Excel, Access, Outlook
• Strong working knowledge of Adobe CS Suite (InDesign, Illustrator, Acrobat), Bartender, or similar label design software required.
• Strong project management, organization and planning skills
• Ability to write clear and effective user instructions
• Ability to communicate effectively with a broad spectrum of people
• Ability to prioritize projects and adapt to shifting priorities.
• High degree of initiative
• Work well in a team environment
• Excellent verbal and written communication skills
• Fluent in spoken and written English
• High level of professionalism
• Excellent customer service skills
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rüsch®, UroLift® and Weck® - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
© 2021 Teleflex Incorporated. All rights reserved.