Complaints Specialist Ii - Shockwave Medical

Johnson & Johnson MedTech

Santa Clara, California, United States of America
$75,000.00 - $120,750.00; not specified; not speci...
Fda, european mdd/mdr compliance
Complaint initiation and assessment
Regulatory geography 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 collaborating with cross-functional teams for timely complaint investigation, coordinating device returns, and completing complaint reporting assessments per geography regulatory medical device reporting requirements.
  • This position requires an Associate’s degree with 4+ years of related Post Market Surveillance experience or a Bachelor’s degree with 2+ years of related Post Market Surveillance experience, with experience in Medical Device Complaint handling, Post Market Surveillance and Regulatory reporting for Class II/III devices being required.

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

$75,000.00 - $120,750.00; Not specified; Not specified

Skills & Requirements

Must-have

  • FDA, European MDD/MDR compliance
  • Complaint initiation and assessment
  • Regulatory geography reporting
  • Device return coordination
  • Cross-functional collaboration
  • Quality compliance and metrics

Nice-to-have

  • Customer and field rep communication
  • Adverse event review
  • Continuous improvement initiatives
  • Audit support

Key Requirements

  • Associate’s degree with 4+ years experience
  • Bachelor’s degree with 2+ years experience
  • Medical Device Complaint handling experience
  • Post Market Surveillance experience
  • Regulatory reporting for Class II/III devices

Work Rights

Not specified

Tailored Resume

Cover Letter