San Diego, California, USA
3 days ago
Labeling Specialist (Med Device)

Job Description:

We are seeking a detail-oriented and collaborative Labeling Specialist to oversee the labeling process for both new and existing In Vitro Diagnostic (IVD) and Medical Device (MD) products. This role requires cross-functional coordination and a strong understanding of regulatory standards to ensure all labeling materials meet specifications and compliance requirements.

Key Responsibilities:

Lead 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 completeness.Design and maintain layouts for product documentation using graphic design tools.Incorporate redlined changes into artwork drafts and finalize source files.Resolve open questions and gather missing information related to redlined artwork.Support labeling creators and reviewers with regulatory guidance for IVD and MD labeling.Proofread and perform quality control checks on product descriptions and labeling content.Create and update barcode label artwork using BarTender software.Manage approvals for labeling requirements and change orders.Provide comprehensive documentation for labeling changes, including redlines, final drafts, source files, change summaries, and translation certificates.Oversee translation projects, including supplier coordination, budget management, and timeline tracking.Coordinate with external suppliers for the procurement and implementation of new and revised labeling materials.

Required Skills & Experience:

Experience in medical device labeling and regulatory compliance.Proficiency in BarTender, Adobe Illustrator, and other graphic design tools.Familiarity with SAP and labeling workflow systems.Strong attention to detail and proofreading skills.Ability to work cross-functionally and manage multiple priorities.

Preferred Qualifications:

Experience with InMotion software.Intermediate-level graphic design expertise.Proven ability to manage translation projects and supplier relationships.

Pay and Benefits

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)

Workplace Type

This is a hybrid position in San Diego,CA.

Application Deadline

This position is anticipated to close on Aug 29, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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