Labeling Specialist
Abbott, Pomona, CA, United States
Title:
Labeling Specialist
Location:
Pomona, California
Duration:
7 Months
100% Onsite
Shift:
7AM TO 4PM
Description:
IVD Labeling & Packaging Designer (In Vitro Diagnostics)
Job Summary We are seeking an experienced IVD Labeling & Packaging Designer to support the design and development of diagnostic product labels. This role is responsible for translating assay design and product requirements into clear, accurate, and effective labeling layouts. The ideal candidate understands how diagnostic assays work, what information must appear on labels, and how to collaborate closely with Regulatory Affairs to ensure compliant content—without needing to be a regulatory expert themselves.
This position plays a critical role in ensuring labeling accuracy, usability, and consistency across IVD products.
Key Responsibilities
Label & Packaging Design
Design IVD product labels and related packaging components (e.g., bottle labels, kit labels, box labels, IFU cover elements)
Ensure label layouts clearly and accurately present required product information
Apply company branding standards while maintaining readability and usability
Assay & Product Understanding
Develop a working understanding of assay principles, reagents, and intended use in order to create accurate label content
Interpret technical inputs such as formulation details, storage conditions, lot/expiry requirements, and product configurations
Ask the right technical questions to ensure label content aligns with the actual assay design
Content Integration & Accuracy
Incorporate required label elements such as:
Product name and description
Intended use summary
Storage and handling conditions
Lot number, expiration date, and symbols
Warnings and limitations
Ensure consistency of information across all labeling components
Cross-Functional Collaboration
Work closely with Regulatory Affairs to incorporate regulatory-required content and feedback
Partner with R&D, Quality, Manufacturing, and Supply Chain to gather label inputs and manage revisions
Support change control activities related to labeling updates
Documentation & File Management
Maintain organized, version-controlled label files and artwork
Support design change implementation and label lifecycle management
Prepare label drafts and revisions for review and approval
Required Qualifications
Bachelor’s degree or certificate in Graphic Design, Life Sciences, Engineering, or a related field, or equivalent experience
Experience designing technical or scientific labels, preferably in IVD, medical devices, or regulated products
Strong ability to understand and interpret assay or reagent-based products
Proficiency with design software (e.g., Adobe Illustrator, InDesign, or similar tools)
High attention to detail and accuracy
Preferred Qualifications
Experience with IVD or diagnostics labeling
Familiarity with label symbols and conventions used in diagnostics or medical products
Experience working in a cross-functional, regulated environment
Regulatory Experience
Deep regulatory expertise is not required
Ability to collaborate effectively with Regulatory Affairs professionals and incorporate regulatory feedback is essential
Key Skills & Competencies
Strong technical comprehension
Excellent communication and collaboration skills
Detail-oriented mindset
Ability to balance design quality with technical accuracy
Comfortable working with structured review and approval processes
Reporting & Collaboration
This position works closely with Regulatory Affairs, R&D, Quality, and Operations
Regulatory guidance and oversight will be provided by a dedicated Regulatory professional
Benefits
Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account (for High-Deductible Health Plans)
Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
Supplemental Life Insurance
Short Term Disability (coverage varies by state)
Long Term Disability
Critical Illness, Hospital coverage, Accident Insurance
MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
401(k)
#J-18808-Ljbffr
Labeling Specialist
Location:
Pomona, California
Duration:
7 Months
100% Onsite
Shift:
7AM TO 4PM
Description:
IVD Labeling & Packaging Designer (In Vitro Diagnostics)
Job Summary We are seeking an experienced IVD Labeling & Packaging Designer to support the design and development of diagnostic product labels. This role is responsible for translating assay design and product requirements into clear, accurate, and effective labeling layouts. The ideal candidate understands how diagnostic assays work, what information must appear on labels, and how to collaborate closely with Regulatory Affairs to ensure compliant content—without needing to be a regulatory expert themselves.
This position plays a critical role in ensuring labeling accuracy, usability, and consistency across IVD products.
Key Responsibilities
Label & Packaging Design
Design IVD product labels and related packaging components (e.g., bottle labels, kit labels, box labels, IFU cover elements)
Ensure label layouts clearly and accurately present required product information
Apply company branding standards while maintaining readability and usability
Assay & Product Understanding
Develop a working understanding of assay principles, reagents, and intended use in order to create accurate label content
Interpret technical inputs such as formulation details, storage conditions, lot/expiry requirements, and product configurations
Ask the right technical questions to ensure label content aligns with the actual assay design
Content Integration & Accuracy
Incorporate required label elements such as:
Product name and description
Intended use summary
Storage and handling conditions
Lot number, expiration date, and symbols
Warnings and limitations
Ensure consistency of information across all labeling components
Cross-Functional Collaboration
Work closely with Regulatory Affairs to incorporate regulatory-required content and feedback
Partner with R&D, Quality, Manufacturing, and Supply Chain to gather label inputs and manage revisions
Support change control activities related to labeling updates
Documentation & File Management
Maintain organized, version-controlled label files and artwork
Support design change implementation and label lifecycle management
Prepare label drafts and revisions for review and approval
Required Qualifications
Bachelor’s degree or certificate in Graphic Design, Life Sciences, Engineering, or a related field, or equivalent experience
Experience designing technical or scientific labels, preferably in IVD, medical devices, or regulated products
Strong ability to understand and interpret assay or reagent-based products
Proficiency with design software (e.g., Adobe Illustrator, InDesign, or similar tools)
High attention to detail and accuracy
Preferred Qualifications
Experience with IVD or diagnostics labeling
Familiarity with label symbols and conventions used in diagnostics or medical products
Experience working in a cross-functional, regulated environment
Regulatory Experience
Deep regulatory expertise is not required
Ability to collaborate effectively with Regulatory Affairs professionals and incorporate regulatory feedback is essential
Key Skills & Competencies
Strong technical comprehension
Excellent communication and collaboration skills
Detail-oriented mindset
Ability to balance design quality with technical accuracy
Comfortable working with structured review and approval processes
Reporting & Collaboration
This position works closely with Regulatory Affairs, R&D, Quality, and Operations
Regulatory guidance and oversight will be provided by a dedicated Regulatory professional
Benefits
Medical and Prescription Drug Plans
Dental Plan
Vision Plan
Health Savings Account (for High-Deductible Health Plans)
Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
Supplemental Life Insurance
Short Term Disability (coverage varies by state)
Long Term Disability
Critical Illness, Hospital coverage, Accident Insurance
MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
401(k)
#J-18808-Ljbffr