Labeling Specialist

Expected Travel: None

Requisition ID: 14116

About Teleflex Incorporated

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

Teleflex is seeking a Labeling Specialist to join our Labeling department! The successful candidate will create and update labeling and product information for medical devices to optimize patient safety and minimize product liability risk. This role will process and track real-time labeling updates through each step of the labeling change process. They will manage labeling data, maintain project documentation, and provide administrative and project support to the team. Additionally, they will apply advanced project management expertise, deliver labeling process training, and collaborate across internal functions and external agencies to ensure regulatory compliance to support business objectives. This position is based at our Maple Grove, Minnesota office location.

Principal Responsibilities

• Leads development of medical device labels from concept through release. Changes are managed in the Agile Quality Management System (QMS).
• Partners with R&D sustaining and new product development teams to develop and Instructions for Use (IFUs), labels, and packaging artwork.
• Partners with Regulatory Affairs, Quality, R&D, Packaging, Clinical, and Marketing teams to maintain real-time data in database/spreadsheet.
• Manages timelines for new and revised labeling projects.
• Audits ongoing and historical label changes for compliance to labeling and Unique Device Identification (UDI) requirements.
• Maintains current knowledge of applicable industry and corporate polices; possesses a working knowledge of Regulatory Affairs and Document Control departments' relevant procedures.
• Support audits as needed.
• Contributes to process improvements for labeling workflows and quality.
• Prepares reports, including metrics, and documentation as requested regarding the labeling process.
• Establishs and maintains effective working relationships with fellow employees to achieve department goals and objectives and maintain good employee relations.
• May provide training and mentorship to the labeling coordinators.
• Works in Smartsheet software - making edits as needed.
• Provide general administrative back-up as required.
• Adhere to and ensure compliance with the Teleflex Code of Ethics, all company policies, rules, and procedures.
• Complete other duties and tasks as assigned.

Education / Experience Requirements

• Bachelor's degree in Engineering, Life Sciences, Graphic Design, Regulatory Affairs, or related field.
• 2-5 years of experience in Medical Device or related industry.
• 1-2 years of experience managing or supporting labeling projects in Medical Device or related industry.

Specialized Skills / Other Requirements

• Strong attention to detail is required.
• Applies good documentation practices and technical writing skills.
• Excellent organizational and 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.
• Smartsheet software - moderate understanding preferred.
• Advanced knowledge of Quality Management Systems/Product Life Management systems.
• Advanced knowledge of medical design labeling graphic software.
• Advanced understanding of non-conformance processes and internal/external audits.
• Advanced understanding of medical device standards and regulations, such as, FDA 21 CRF 801,

ISO 5223-1, MDR Regulation (EU) 2017/745) EU requirements.

• Advanced understanding of barcodes, such as, UDI, GS1 and general barcode standards.
• Strong verbal and written communication skills are required.
• Intermediate proficiency in English is required - Advanced is preferred.

Working Conditions / Physical Demands

• Strong attention to detail is required.
• Applies good documentation practices and technical writing skills.
• Excellent organizational and 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.
• Smartsheet software - moderate understanding preferred.
• Advanced knowledge of Quality Management Systems/Product Life Management systems.
• Advanced knowledge of medical design labeling graphic software.
• Advanced understanding of non-conformance processes and internal/external audits.
• Advanced understanding of medical device standards and regulations, such as, FDA 21 CRF 801,

ISO 5223-1, MDR Regulation (EU) 2017/745) EU requirements.

• Advanced understanding of barcodes, such as, UDI, GS1 and general barcode standards.
• Strong verbal and written communication skills are required.
• Intermediate proficiency in English is required - Advanced is preferred.

The pay range for this position at commencement of employment is expected to be between ($69,700-$89,600) however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

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