Complaints Specialist Ii - Shockwave Medical

Johnson & Johnson Innovative Medicine

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
The Complaints Specialist II will perform work under general supervision, ensuring compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and assessment of regulatory geography reporting

Job Summary

  • The Complaints Specialist II will perform work under general supervision, ensuring compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and assessment of regulatory geography reporting.
  • Essential job functions include coordinating device returns, collaborating with cross-functional teams for investigations, and completing complaint reporting assessments per geography regulatory medical device reporting requirements.
  • The anticipated base pay range for this position is $75,000.00 - $120,750.00, with eligibility for the Company’s consolidated retirement plan, savings plan, and long-term incentive program.

Matching Summary

The Complaints Specialist II will perform work under general supervision, ensuring compliance to the Complaints and Post Market Surveillance System with the responsibility of timely complaint initiation and assessment of regulatory geography reporting.

Salary

Base: $75,000.00 - $120,750.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off

Skills & Requirements

Must-have

  • Medical Device Complaint handling
  • Post Market Surveillance
  • Regulatory reporting
  • FDA/ISO Audits
  • Quality Management Systems (QMS)

Nice-to-have

  • Continuous Improvement
  • Business Behavior
  • Process Oriented
  • Goal Attainment
  • Customer Service Support

Key Requirements

  • Associate’s degree with 4+ years of experience
  • Bachelor’s degree with 2+ years of experience
  • Class II/III devices experience
  • Proficiency in data compilation and analysis
  • Excellent written and verbal communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter