Clinical Complaint Risk Analyst

BD

Covington, Georgia, United States
Fully remote
Mdr/adverse event reporting
Clinical use of product evaluation
Adverse event/complaint trend analysis
The Clinical Risk Specialist II will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence/risk, analyze adverse events/complaint trends, and respond to regulatory inquiries

Job Summary

  • The Clinical Risk Specialist II will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence/risk, analyze adverse events/complaint trends, and respond to regulatory inquiries.
  • This position will ensure that all product complaints are documented, investigated, and reported in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Division, and International policies and procedures.
  • At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry.

Matching Summary

The Clinical Risk Specialist II will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence/risk, analyze adverse events/complaint trends, and respond to regulatory inquiries.

Skills & Requirements

Must-have

  • MDR/adverse event reporting
  • clinical use of product evaluation
  • adverse event/complaint trend analysis
  • regulatory inquiry response
  • Quality Systems regulations
  • ISO requirements
  • FDA regulations

Nice-to-have

  • advancing the world of health
  • transformative solutions
  • human element across global teams
  • culture of excellence
  • work-life balance

Key Requirements

  • 3 years clinical experience preferred
  • 3 years medical device industry experience
  • Complaint handling software experience
  • TrackWise or equivalent experience
  • Access Databases experience
  • Excel (Pivot Tables and Charts) experience
  • Bachelor's degree required
  • Nursing degree preferred

Work Rights

Not specified

Tailored Resume

Cover Letter