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Johnson & Johnson is seeking a Senior Labeling Specialist for its Shockwave Medical division in Santa Clara, CA. The role involves creating and managing product labels and instructions for use (IFUs) to ensure compliance with regulatory standards, while collaborating across various departments in a fast-paced environment.
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Job Summary
The Sr. Labeling Specialist is responsible for creating, designing, and releasing product labels and instructions for use (IFUs) that comply with applicable regulations.
This role partners with Regulatory, Quality, Supply Chain, R&D and Manufacturing Engineering to ensure accurate and compliant production labeling.
Employees and/or eligible dependents may be eligible to participate in various Company sponsored employee benefit programs including medical, dental, vision, and retirement plans.
Matching Summary
Match Score: 75
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Johnson & Johnson is seeking a Senior Labeling Specialist for its Shockwave Medical division in Santa Clara, CA. The role involves creating and managing product labels and instructions for use (IFUs) to ensure compliance with regulatory standards, while collaborating across various departments in a fast-paced environment.
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Salary
Base: $91,000.00 - $147,200.00; Bonus/Equity: eligible for annual performance bonus; Benefits: medical, dental, vision, life insurance, disability, retirement plan
Skills & Requirements
Must-have
product labeling and instructions for use
regulatory labeling requirements
labeling change-control lifecycle
label content accuracy and compliance
medical device labeling experience
Nice-to-have
adapt to changing requirements
collaborative and independent work
detail-oriented and organized
Key Requirements
4-7 years of experience in medical device labeling
Bachelor’s degree or equivalent experience
Strong working knowledge of regulatory labeling requirements