Labeling Specialist II – Abbott, Sylmar, California
Location: Sylmar, California
Company: Abbott
Job Type: Full-Time
Work Mode: On-site
Salary Range: $79,500 – $138,700 (based on location and experience)
Job Summary
Abbott is seeking a Labeling Specialist II to join its Cardiac Rhythm Management Division in Sylmar, California. This role is responsible for managing medical device labeling and Instructions for Use (IFU) to ensure global regulatory compliance, working closely with cross-functional teams including engineering, regulatory affairs, marketing, and clinical departments. The ideal candidate will bring significant experience in labeling, regulatory documentation, or medical device compliance.
Key Responsibilities
Create and maintain medical device labeling and IFU documentation.
Ensure labeling complies with global regulatory requirements including FDA, EU MDR, and ISO standards.
Collaborate with cross-functional teams to gather input and manage changes.
Utilize tools such as Adobe Illustrator, InDesign, Photoshop, Label Vision, and EasyLabel.
Support regulatory submissions with labeling documents.
Oversee artwork development and review for accuracy and compliance.
Manage labeling change orders, document revisions, and audit trails.
Lead or support labeling improvement projects.
Coordinate with internal print teams and external vendors.
Required Qualifications
Bachelor’s degree in a relevant field or equivalent experience.
Minimum 3 years of experience in labeling, regulatory affairs, or related areas within a regulated industry.
Proficiency with Adobe Creative Suite (Illustrator, InDesign, Photoshop).
Experience with labeling software such as Label Vision and EasyLabel.
Familiarity with ERP systems such as SAP and documentation tools like PDM.
Knowledge of regulatory labeling standards including FDA, ISO 15223, ISO 20417, and EU MDR.
Strong written and verbal communication skills.
Proven ability to manage multiple tasks and priorities.
Compensation and Benefits
Salary range: $79,500 – $138,700
Medical coverage under Health Investment Plan (HIP PPO)
401(k) retirement plan with employer contributions
Tuition reimbursement and student debt assistance programs
Access to FreeU for bachelor’s degree completion
Leadership development and global mobility opportunities
Inclusion in Abbott's award-winning culture recognized by Fortune and others
Travel requirement: Approximately 5 percent
About Abbott
Abbott is a global healthcare leader delivering trusted solutions in diagnostics, medical devices, nutrition, and branded generic medicines. With over 114,000 employees in 160+ countries, Abbott is committed to helping people live healthier lives through innovative products and technologies.
Call to Action
If you have a strong background in labeling, regulatory compliance, or medical device documentation, take the next step in your career with Abbott. Apply today and contribute to a company making a real difference in global healthcare.
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