Sr. Labeling Specialist - Shockwave Medical

Johnson & Johnson Innovative Medicine

Santa Clara, California, United States of America
Base: $91,000.00 - $147,200.00; bonus/equity: elig...
Not specified (assumed to be on-site as location is given)
Medical device labeling
Product labels and ifus
Regulatory labeling requirements
Johnson & Johnson is seeking a Sr. Labeling Specialist for its Shockwave Medical division in Santa Clara, CA. The role focuses on the creation and management of product labels and instructions for use, ensuring compliance with regulatory standards

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 may be eligible to participate in various Company sponsored employee benefit programs including medical, dental, vision, and retirement plans.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Sr. Labeling Specialist for its Shockwave Medical division in Santa Clara, CA. The role focuses on the creation and management of product labels and instructions for use, ensuring compliance with regulatory standards.

Salary

Base: $91,000.00 - $147,200.00; Bonus/Equity: eligible for an annual performance bonus; Benefits: medical, dental, vision, life insurance, disability, retirement plan, savings plan, vacation, sick time, holiday pay, work/personal/family time

Skills & Requirements

Must-have

  • medical device labeling
  • product labels and IFUs
  • regulatory labeling requirements
  • labeling change-control lifecycle
  • label master files and version control
  • labeling documentation within PLM, ERP

Nice-to-have

  • adapt to changing requirements
  • collaborative and independent work
  • fast-paced environment
  • strong communication and editing skills

Key Requirements

  • 4–7 years of experience in medical device labeling
  • Bachelor’s degree in life sciences, regulatory affairs, technical writing, communications, or related discipline
  • Experience managing IFU and label content changes under a QMS
  • Proficiency with label/artwork file formats and MS Office

Work Rights

Not specified

Tailored Resume

Cover Letter