Labeling Coordinator 3

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.

Principal 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.

Education / Experience Requirements

• High school diploma or equivalent 
• 4-7 yrs Experience in Medical Device or related industry  
• College diploma in related field is preferred

Specialized Skills / Other Requirements

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. 
Smartsheet software – moderate understand preferred. 
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 – Advanced is preferred. 

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