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Labeling Coordinator Jobs (NOW HIRING)

JenaValve

Specialist, Labeling Control

Irvine, CA · On-site

$82K/yr

Support and execute labeling change control activities, including performing impact assessments related to regulatory, manufacturing, and patient safety considerations, coordinating cross-functional ...

New

Almac Group

Label Design Coordinator

Souderton, PA

The Label Design Coordinator will design/create clinical study labels using label generation software in accordance with customer specifications and parameters. Responsibilities include but are not ...

Almac Group

Label Design Coordinator

Souderton, PA · On-site

The Label Design Coordinator will design/create clinical study labels using label generation software in accordance with customer specifications and parameters. Responsibilities include but are not ...

Experis

Loftware Labeling Project Manager

New Brunswick, NJ · Remote

$101.70K - $120.30K/yr

Lead coordination of Loftware labeling system deployments and migration activities * Support operational readiness for labeling systems during manufacturing site cutovers * Coordinate integrations ...

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How much do labeling coordinator jobs pay per hour?

As of May 31, 2026, the average hourly pay for labeling coordinator in the United States is $24.57, according to ZipRecruiter salary data. Most workers in this role earn between $16.11 and $31.97 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Labeling Coordinator, and why are they important?

To thrive as a Labeling Coordinator, you need a solid understanding of regulatory requirements, attention to detail, and experience with documentation management, often supported by a degree in life sciences or a related field. Familiarity with labeling software, document control systems, and regulatory submission tools is typically required. Strong organizational skills, effective communication, and the ability to collaborate across departments are important soft skills in this role. These skills ensure accurate and compliant product labeling, minimize regulatory risks, and support efficient product launches.

How does a Labeling Coordinator typically collaborate with regulatory, production, and quality assurance teams?

As a Labeling Coordinator, collaboration with regulatory, production, and quality assurance teams is essential to ensure all product labels meet compliance standards and are accurately implemented. You’ll frequently work with regulatory teams to interpret guidelines, coordinate with production to synchronize label changes with manufacturing schedules, and partner with quality assurance to review and approve final proofs. Effective communication and organizational skills are crucial, as you’ll often facilitate meetings, track documentation, and resolve discrepancies across departments. This cross-functional teamwork helps maintain both regulatory compliance and operational efficiency.

What does a Labeling Coordinator do?

A Labeling Coordinator is responsible for managing and overseeing the creation, review, and approval of product labels to ensure they comply with regulatory standards and company requirements. They work closely with various departments, such as regulatory affairs, marketing, and manufacturing, to coordinate label changes and updates. Their duties may also include maintaining labeling documentation, ensuring accuracy, and managing timelines for label production. Labeling Coordinators play a key role in ensuring that products are accurately and legally represented in the marketplace.
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Labeling Coordinator jobs near you
Infographic showing various Labeling Coordinator job openings in the United States as of May 2026, with employment types broken down into 49% Full Time, 45% Part Time, 3% Temporary, and 3% Contract. Highlights an 66% Physical, and 34% Remote job distribution, with an average salary of $51,116 per year, or $24.6 per hour.
Specialist, Labeling Control

Specialist, Labeling Control

JenaValve

Irvine, CA • On-site

$82K/yr

Full-time

Posted yesterday

Job description

Job Title: Specialist, Labeling Control
Role Level: Individual Contributor (IC)
Supervisor/Manager Title: Senior Manager, Corporate Quality Systems
Job Location & Environment: Irvine, CA - Corporate Office
Job Description Summary: The Labeling Control Quality Specialist supports labeling-related elements of the JenaValve Quality Management System (QMS) to ensure compliance with global medical device regulations and standards. This role provides quality oversight for the development, control, and validation of product labeling, including but not limited to device labels, IFUs/eIFUs, and patient implant cards, ensuring alignment with approved technical documentation and regulatory requirements. Working cross-functionally with Regulatory Affairs and Labeling Operations, the specialist supports labeling accuracy, change control, printing processes, and investigations, while maintaining a strong focus on patient safety, regulatory compliance, and audit readiness.
Job Responsibilities:
Quality System Support Activities may include:
  • Support maintenance of labeling-related processes within the QMS in alignment with 21 CFR Part 820, 21 CFR Part 801, 21 CFR Part 830 (UDI), ISO 13485:2016, and EU MDR (Regulation (EU) 2017/745), including Annex I, II, and VI requirements.
  • Provide quality oversight for labeling development, review, approval, and implementation for final product labels, Instructions for Use (IFU and eIFU), and patient implant cards.
  • Ensure labeling content is accurate, compliant, and consistent with approved technical documentation (Annex II), regulatory submissions, device claims, product configurations, and UDI requirements.
  • Review and approve labeling to ensure compliance with ISO 15223-1 (medical device symbols), ISO 20417 (information supplied by the manufacturer), ISO 5840 (cardiovascular implant labeling), and EU MDR Annex I Chapter III labeling and IFU requirements.
  • Support UDI implementation and maintenance, ensuring alignment between labeling, regulatory databases, and product identification requirements.
  • Participate in labeling design and updates using LabelView or similar labeling software, ensuring proper formatting, controlled data inputs, and labeling integrity.
  • Ensure proper document control of labeling artwork and content, including version control, change history, and approval workflows in accordance with QMS requirements
  • Support and execute labeling change control activities, including performing impact assessments related to regulatory, manufacturing, and patient safety considerations, coordinating cross-functional reviews and approvals, and ensuring controlled implementation.
  • Support and/or lead investigations related to labeling, including labeling nonconformances, printing errors in both in-house and supplier-managed processes, and complaints associated with labeling content or IFU accuracy.
  • Support and/or execute label validation and verification activities to ensure label content accuracy, correct UDI and product identifiers, proper use of regulatory symbols, print quality, readability, durability, barcode accuracy and scannability, and alignment between approved artwork and final printed output.
  • Participate in validation of labeling processes, including supporting equipment qualification and validation activities (IQ/OQ/PQ as applicable), assisting with labeling software validation (e.g., LabelView), and ensuring controlled and validated data flows between systems.
  • Ensure labeling and printing processes comply with validation requirements.
  • Support audits and inspections by providing labeling-related documentation and demonstrating compliance with global regulatory requirements and internal procedures.
  • Contribute to continuous improvement of labeling processes and systems to enhance patient safety, product quality, and regulatory compliance.

Required Education and Experience:
  • Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline
  • 1-3+ years of experience in a regulated medical device environment, preferably supporting Class II or Class III devices
  • Working knowledge of Quality Management Systems, including ISO 13485 and 21 CFR Part 820
  • Familiarity with global medical device labeling requirements, including 21 CFR Part 801 and EU MDR Annex I and Annex VI
  • Understanding of labeling standards, including ISO 15223-1, ISO 20417, and preferably ISO 5840 for cardiovascular devices
  • Experience or exposure to UDI systems, labeling traceability, labeling control processes, artwork management, and document control systems
  • Experience with LabelView or similar labeling software preferred
  • Experience supporting or participating in label validation and verification activities, including inspection of printed labels, verification of labeling content against approved artwork, barcode and UDI verification, and basic process validation concepts applied to labeling systems and printing processes
  • Familiarity with label validation practices, including barcode verification, print quality assessment, and validation documentation (protocols, reports, and traceability)

Skills and Abilities Required for This Job:
  • Self-starter and the ability to conduct hands-on work with minimal supervision.
  • Work effectively and collaborate within cross-functional teams.
  • Strong communication and stakeholder management.
  • Ability to manage multiple priorities.
  • Data integrity mindset and high attention to detail.
  • Analytical and structured problem solving.
  • Good oral and written communication skills.
  • Commitment to continuous improvement

Physical Requirements:
  • Prolonged periods of sitting, computer use, and detailed visual inspection of labeling artwork, printed materials, and electronic documentation for accuracy and compliance.
  • Occasional time spent in manufacturing or packaging environments, which may include standing, walking, and performing hands-on label inspection activities, with adherence to applicable GMP and site safety requirements (including PPE as required).

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