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.
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