Complaints Specialist Ii - Shockwave Medical

Johnson & Johnson

Santa Clara, California, United States of America
Base: $75,000.00 - $120,750.00; bonus/equity: elig...
Medical device complaint handling
Post market surveillance
Regulatory reporting compliance
Johnson & Johnson is pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease

Job Summary

  • Johnson & Johnson is pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.
  • The Complaints Specialist II ensures compliance with FDA, European MDD/MDR, and other international regulations while managing complaint initiation, assessment, and reporting.
  • Employees are eligible for comprehensive benefits including retirement plans, paid time off, parental leave, and participation in the company’s long-term incentive program.

Matching Summary

Johnson & Johnson is pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

Salary

Base: $75,000.00 - $120,750.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Retirement plans, paid time off, parental leave, volunteer leave

Skills & Requirements

Must-have

  • Medical Device Complaint Handling
  • Post Market Surveillance
  • Regulatory Reporting Compliance
  • Complaint Investigation Coordination
  • Quality Management Systems (QMS)
  • Customer Communication
  • Complaint Device Return Coordination

Nice-to-have

  • FDA/ISO Audit Experience
  • CAPA and NCR Knowledge
  • Data Analysis and Presentation
  • Strong Time Management
  • Team Collaboration
  • Continuous Improvement Focus
  • Excellent Written Communication

Key Requirements

  • Associate’s degree with 4+ years Post Market Surveillance experience
  • Bachelor’s degree with 2+ years Post Market Surveillance experience
  • Experience with Class II/III medical device complaint handling
  • Proficiency in MS Word, Excel, PowerPoint
  • Strong written and verbal communication skills

Work Rights

Not specified

Tailored Resume

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