Complaints Specialist Ii - Shockwave Medical

Johnson & Johnson

Santa Clara, California, United States of America
Base: $75,000.00 - $120,750.00; bonus/equity: elig...
Complaints and post market surveillance system
Regulatory geography reporting
Complaint device returns coordination
The Complaints Specialist II will perform work under general supervision to ensure compliance with the Complaints and Post Market Surveillance System, including timely complaint initiation, assessment of regulatory reporting, and coordination of complaint device returns

Job Summary

  • The Complaints Specialist II will perform work under general supervision to ensure compliance with the Complaints and Post Market Surveillance System, including timely complaint initiation, assessment of regulatory reporting, and coordination of complaint device returns.
  • This role requires collaboration with cross-functional engineers and technicians for timely complaint investigation completion and maintaining quality compliance to achieve quality metrics.
  • 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 to ensure compliance with the Complaints and Post Market Surveillance System, including timely complaint initiation, assessment of regulatory reporting, and coordination of complaint device returns.

Salary

Base: $75,000.00 - $120,750.00; Bonus/Equity: Eligible for long-term incentive program; Benefits: Company's consolidated retirement plan (pension) and savings plan (401(k)), 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

  • Complaints and Post Market Surveillance System
  • Regulatory geography reporting
  • Complaint device returns coordination
  • FDA, European MDD/MDR & International Regulations
  • Medical Device Complaint handling
  • Post Market Surveillance
  • Regulatory reporting for Class II/III devices

Nice-to-have

  • Continuous improvement and ongoing compliance
  • Support internal and external audits
  • Customer and Shockwave Medical reps feedback
  • Data compilation, analysis, presentation

Key Requirements

  • Associate’s degree with 4+ years of Post Market Surveillance experience
  • Bachelor’s degree with 2+ years of Post Market Surveillance experience
  • Experience with FDA/ISO Audits, NCR, and CAPA experience is a plus
  • Proficiency in data compilation, analysis, presentation, and document writing
  • Ability to understand and follow QMS Procedures

Work Rights

Not specified

Tailored Resume

Cover Letter