Labeling Specialist

Labeling Specialist

Responsible for overseeing the labeling process for both new and existing in vitro diagnostic (IVD) and medical device (MD) products. This role requires cross-functional collaboration to ensure labeling deliverables meet regulatory, design, and operational standards.

Manage the development and revision of product labeling, including manuals, Instructions for Use (IFUs), packaging, and labels.

Collaborate with Marketing, Regulatory Affairs, Supply Chain, Engineering, Clinical, and Manufacturing teams to ensure labeling accuracy and compliance.

Incorporate redlined changes into artwork drafts and source files; resolve open questions and request missing information.

Provide guidance to labeling creators and reviewers based on a strong understanding of regulatory standards and guidelines for IVD and MD labeling.

Proofread and perform quality control checks on product descriptions and labeling content.

Create and revise barcode label artwork and source files using BarTender software.

Secure necessary approvals for labeling requirements and changes.

Prepare documentation for labeling change orders, including redlines, final artwork drafts, source files, change summaries, and translation certificates.

Manage translation projects, including supplier coordination, budget tracking, and timeline management.

Coordinate with external suppliers to facilitate the ordering, receipt, and implementation of new and revised labeling.

Experience in medical device labeling and regulatory compliance

Proficiency in graphic design tools, including Adobe Illustrator and InMotion

Familiarity with BarTender software for barcode labeling

Working knowledge of SAP or similar ERP systems

Strong attention to detail and proofreading capabilities

Ability to collaborate effectively across departments

Intermediate Candidates should have relevant experience in labeling within the medical device or diagnostics industry, along with demonstrated graphic design proficiency.

The pay range for this position is $36.06 - $45.67/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in San Diego,CA.

This position is anticipated to close on Sep 5, 2025.