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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Working Conditions / Physical Demands

The pay range for this position at commencement of employment is expected to be between ($54,200-81,300)  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.