Job Summary
Abbott is seeking a Labeling Specialist II for its Cardiac Rhythm Management Division in Sylmar, California. This role involves developing and maintaining compliant labeling for medical devices, including Instructions for Use (IFUs), product labels, and packaging documentation. The ideal candidate will bring a strong understanding of FDA and global labeling regulations, as well as technical proficiency in tools like Adobe Illustrator, InDesign, and SAP. This position offers the opportunity to contribute to life-saving technologies while working in a highly regulated, collaborative environment.
Key Responsibilities
Collaborate with cross-functional teams to define, develop, and review labeling content.
Design and maintain IFUs, labels, and packaging using Adobe Illustrator and other design tools.
Ensure labeling compliance with global regulatory requirements including FDA and EU MDR.
Manage labeling artwork, change orders, and vendor communications.
Participate in the development of new labeling processes and continuous improvement initiatives.
Support labeling for new product development, product updates, and global submissions.
Ensure accurate documentation and archive of labeling-related files.
Provide labeling input during audits and regulatory inspections.
Mentor junior labeling staff and manage smaller-scale projects as needed.
Assist in print quality assurance checks and approve proofs with vendors.
Required Skills and Qualifications
Bachelor’s degree or equivalent experience in a related field.
Minimum 3 years of experience in labeling, preferably in the medical device or pharmaceutical industry.
Proficiency with Adobe Illustrator, InDesign, Photoshop, and Microsoft Office.
Experience working with enterprise systems such as SAP, ERP, MES, or Product Lifecycle Management tools.
Solid understanding of FDA, ISO, and other international labeling requirements.
Strong written communication, editing, and formatting skills.
Ability to manage multiple priorities, timelines, and cross-functional collaboration.
Detail-oriented with strong problem-solving and decision-making abilities.
Willingness to travel up to 5 percent, including internationally.
Salary and Benefits
Base salary range: $79,500 to $138,700
Free medical coverage under the Health Investment Plan (HIP PPO)
Retirement savings plan with employer contributions
Tuition reimbursement and student loan assistance programs
Access to FreeU bachelor’s degree education support
Career advancement within a global Fortune 500 healthcare company
Company Overview
Abbott is a global leader in healthcare, with a presence in more than 160 countries. The company delivers innovative solutions across diagnostics, medical devices, nutrition, and branded generic medicines. With a legacy of over 130 years, Abbott is dedicated to advancing health and improving life through technology and science.
Work Location
On-site
Sylmar, California, United States
Call to Action
If you are an experienced labeling professional with a passion for regulatory compliance and medical device innovation, Abbott invites you to apply. Join a mission-driven team dedicated to improving patient outcomes across the world.
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