Labeling Specialist

Posted 9 Days Ago
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Kennesaw, GA, USA
Hybrid
Mid level
Biotech
The Role
Coordinate creation, review, approval, release, and implementation of medical device product labels. Ensure regulatory and internal compliance, manage translations and proofs, support production with correct labels, perform quality checks, resolve discrepancies, document processes, and collaborate with Operations, Quality, Regulatory, Engineering, and Supply Chain to implement label changes and continuous improvements.
Summary Generated by Built In

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,600 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Overview:

This position is responsible for coordinating, updating and maintaining accurate product labeling to support operational, regulatory, and quality requirements. This role works closely with Operations, Quality, Regulatory, Marketing, and Supply Chain teams to ensure labels are created, approved, and updated in production systems.

Responsibilities: 

  • Prepare and coordinate the creation, review, approval, release, and implementation of product labels
  • Ensure labels comply with internal standards and applicable regulatory requirements
  • Coordinate obtaining translations and proofs from outside vendors
  • Become proficient with labeling software, templates, and version control systems
  • Support production schedules by ensuring correct labels are available when needed
  • Become proficient with label printers and LVS systems to assist with minor problems
  • Prepare and coordinate label changes due to regulatory updates, product changes, or process improvements, including any associated document changes required as part of label updates.
  • Perform quality checks to verify label accuracy, formatting, and revision control
  • Collaborate with cross-functional teams (Operations, Quality, Regulatory, Engineering)
  • Document labeling processes and support audits or inspections
  • Investigate and resolve labeling errors or discrepancies. Proactively identify opportunities to eliminate labeling errors.
  • Identify gaps and perceived operational issues and prepare proposals on areas for improvement.
  • Works Independently to moderately complex labeling changes

Qualifications: 

  • Bachelor’s degree in Operations, Supply Chain, Life Sciences, or a related field
  • 25 years of experience in labeling, operations, manufacturing, or supply chain coordination
  • Experience in regulated environments (e.g., pharmaceuticals, medical devices, food) is a plus
  • Strong attention to detail and organizational skills
  • Ability to manage multiple tasks and deadlines
  • Familiarity with labeling systems, document control, or ERP systems
  • Strong written and verbal communication skills
  • Problem-solving and root-cause analysis skills
  • Proficiency in Microsoft Office (Excel, Word)
  • Ability to work independently and collaboratively
  • Knowledge of regulatory labeling requirements
  • Experience with change control or quality management systems
  • Continuous improvement mindset

This is a hybrid position that will report to our Kennesaw, GA location 3 days per week. 

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Skills Required

  • Bachelor's degree in Operations, Supply Chain, Life Sciences, or related field
  • 2-5 years of experience in labeling, operations, manufacturing, or supply chain coordination
  • Familiarity with labeling systems, document control, or ERP systems
  • Proficiency in Microsoft Office (Excel, Word)
  • Strong attention to detail and organizational skills
  • Ability to manage multiple tasks and deadlines
  • Strong written and verbal communication skills
  • Problem-solving and root-cause analysis skills
  • Knowledge of regulatory labeling requirements
  • Experience with change control or quality management systems
  • Experience in regulated environments (pharmaceuticals, medical devices, food)
  • Continuous improvement mindset
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The Company
HQ: Kennesaw, GA
740 Employees
Year Founded: 1984

What We Do

Artivion is a leader in the manufacturing, processing, and distribution of medical devices and implantable tissues used in cardiac and vascular surgical procedures focused on aortic repair. Our purpose is to develop simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with diseases of the aorta and deliver breakthrough technologies of unsurpassed quality that have far-reaching impact. Our decades of expertise in treating aortic diseases—coupled with our recent acquisitions and partnerships—have empowered us to offer cardiac and vascular surgeons a suite of aortic-centric solutions such as cryopreserved cardiac and vascular allografts, surgical sealants, prosthetic heart valves, and aortic stents and stent-grafts. Artivion has over 1,250 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas, and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America.

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