Labeling Specialist

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.