Labeling Coordinator 3

Teleflex•Durham, NC

6d•Onsite

About The Position

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives. Position Summary Process labeling change request projects and track real-time updates through each step of the labeling change process. Manage Labeling data collection activities and provide requested reports. Maintain labeling project documentation, plans and reports. Provide general administrative back-up as required. Provide project support to project team. Advanced understanding of project management. Supports internal department training on labeling process.

Requirements

High school diploma or equivalent
4-7 yrs Experience in Medical Device or related industry
Strong attention to detail is required.
Applies Good Documentation Practices.
Excellent organizational skills.
Problem solving skills.
Consistently displays a proactive and collaborative approach to assigned tasks
Ability to understand established procedures and regulations.
Ability to work in a professional manner while under pressure and tight timelines.
MS Office Suite – advanced understanding.
Advanced knowledge of non-conformance processes.
Advanced understanding of internal and external audits; standard in medical device industry.
Advanced knowledge of Quality Management Systems/Product Life Management systems.
Advanced understanding of medical device standards and regulations, such as, FDA 21 CRF 801, ISO 15223-1, MDR Regulation (EU) 2017/745) EU requirements.
Strong verbal and written communication skills are required.
Intermediate proficiency in English is required

Nice To Haves

College diploma in related field is preferred
Smartsheet software – moderate understand preferred.
Advanced knowledge of medical design labeling graphic software.
Advanced is preferred for English proficiency.

Responsibilities

Compile and maintain electronic labeling files (including redlines) as well as hard copy packages. Changes are managed in the Agile Quality Management System (QMS).
Audit ongoing and historical labeling changes for compliance to labeling requirements.
Responsible for ensuring execution and timely reviewal and approval of label change requests.
Develop and maintain a regular schedule for following up on open change orders.
Receive updates from approvers and maintain real-time data in database/spreadsheet for each step in the label change process.
Preparation of reports, including metrics, and documentation as requested regarding the labeling process.
Respond to requests for labeling change updates / status.
Provide general administrative back-up as required.
Interact with internal labeling staff and labeling customers to ensure accurate and timely completion of labeling change orders.
Maintains current knowledge of applicable industry and corporate polices; possesses a working knowledge of Regulatory Affairs and Document Control departments’ relevant procedures.
Establish and maintain effective working relationships with fellow employees to achieve department goals and objectives and maintain good employee relations.
Responds to and maintains communication with sustaining and new product development labeling and iInstruction for use (IFU) tasks with business unit team members.
Support audits if needed.
May be asked to provide training to others.
Works in Smartsheet software – making edits as needed.
Other tasks as assigned by manager.