Labeling Coordinator 3

Teleflex Incorporated•Maple Grove, MN

4d•Onsite

About The Position

Teleflex Incorporated is a global provider of medical technologies dedicated to improving people's lives. The Global Operations department is responsible for end-to-end product fulfillment and focuses on customer centricity, improving quality, service, and value. This role supports a dynamic, growing team that offers healthcare providers medical technology solutions that make a difference in patients’ lives. This position is responsible for processing labeling change request projects, tracking real-time updates, managing labeling data collection, and providing requested reports. The role also involves maintaining labeling project documentation, providing general administrative backup, and offering project support to the project team. An advanced understanding of project management is expected, and the role includes supporting internal department training on the labeling process.

Requirements

High school diploma or equivalent
4-7 years of 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 knowledge of medical design labeling graphic software.
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 proficiency in English is preferred.

Responsibilities

Compile and maintain electronic labeling files (including redlines) as well as hard copy packages, managed in the Agile Quality Management System (QMS).
Audit ongoing and historical labeling changes for compliance to labeling requirements.
Ensure 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.
Prepare 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.
Maintain current knowledge of applicable industry and corporate policies; possess 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.
Respond to and maintain communication with sustaining and new product development labeling and Instruction for Use (IFU) tasks with business unit team members.
Support audits if needed.
May be asked to provide training to others.
Work in Smartsheet software – making edits as needed.
Other tasks as assigned by manager.