Clinical Complaint Risk Analyst

BD

Covington, GA, USA
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 compliance
  • ISO requirements adherence
  • FDA regulations adherence

Nice-to-have

  • human element across global teams
  • transformative solutions
  • imagination and passion

Key Requirements

  • Bachelor’s degree required
  • 3 years of clinical experience preferred
  • 3 years in medical device industry preferred
  • Experience in complaint handling software
  • Extensive knowledge of medical device regulations
  • Extensive knowledge of Quality Systems regulations

Work Rights

Not specified

Tailored Resume

Cover Letter