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Labeling Specialist Ii

6+ years
$79,500 – $138,700 annually
10 June 20, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Labeling Specialist II – On-site (Sylmar, CA)

Job Summary

Abbott’s Cardiac Rhythm Management Division in Sylmar, California is hiring a skilled Labeling Specialist II to design, update, and maintain medical device labeling, including Instructions for Use (IFUs) and product labels. The role involves cross-functional collaboration with engineering, marketing, clinical research, and regulatory affairs to ensure labeling accuracy, visual appeal, regulatory compliance, and cost efficiency.


Key Responsibilities

  • Gather and interpret labeling requirements from Engineering, Marketing, Clinical Research, and Regulatory Affairs.

  • Coordinate labeling content to meet marketing, geographical, and regulatory requirements.

  • Edit IFUs for grammar, consistency, and formatting to enhance professional quality and clarity.

  • Assist in regulatory submissions by providing accurate labeling samples and related documents.

  • Produce and update labeling artwork using design software like Adobe Photoshop, Illustrator, InDesign, and EasyLabel.

  • Prepare and manage Change Orders (COs) and label specifications for cross-functional approvals.

  • Maintain a comprehensive labeling history file, archiving previous versions for reference.

  • Ensure internal labeling procedures meet legal and regulatory compliance standards.

  • Recommend and implement improvements to labeling processes, tools, and technologies.

  • Mentor junior staff and guide team projects as needed.

  • Attend print production checks and approve labeling print quality in coordination with vendors.


Required Skills & Qualifications

  • Bachelor’s Degree in a related field (or equivalent work experience).

  • Minimum 6 years of relevant experience in labeling, regulatory affairs, or related fields.

  • Expertise in labeling software such as Adobe Photoshop, Illustrator, InDesign, and EasyLabel.

  • Strong attention to detail with exceptional grammar, spelling, and editing skills.

  • Ability to manage multiple projects with shifting priorities and tight deadlines.

  • Excellent written and verbal communication skills.

  • Familiarity with FDA regulations and quality system requirements.

  • Strong organizational and project management abilities.

  • Ability to work both independently and collaboratively within teams.


Perks & Benefits

  • Salary Range: $79,500 – $138,700 annually.

  • Free medical coverage under HIP PPO plan (subject to eligibility).

  • High employer contribution towards a 401(k) retirement savings plan.

  • Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit.

  • Career advancement opportunities in a globally recognized healthcare company.


Company Description

Abbott is a global leader in healthcare innovation, offering pioneering solutions in diagnostics, medical devices, nutrition, and pharmaceuticals. The Cardiac Rhythm Management Division develops life-saving technologies that improve heart health worldwide.


Work Mode

On-site – Sylmar, California, United States


Call to Action

Ready to shape the future of medical device labeling? Apply now to join Abbott and make an impact in delivering life-changing healthcare technologies.