What are the responsibilities and job description for the Global Recall Specialist position at Compri Consulting?
Client located in Lakewood, Colorado is seeking a Sr. Global Recall Specialist for a long-term contract position. This person will assist an established team managing product recalls, interfacing with the FDA representatives, documenting recall activities, and providing training to other team members. The ideal candidate will help the client implement best practices regarding recall processes and procedures.
Required:
-Experience as a recall coordinator.
-Medical device or similar product recall experience in a heavily regulated industry.
-Familiarity with Field Alert Reports (FAR).
-Familiarity with FDA 21 CFR Part 7, 21 CFR Part 806, and ISO 13485:2016.
-Bachelor's degree.
Desired:
-Regulatory Affairs Certification (RAC).
-ISO 12485 Lead Auditor Certification.
-ASQ Certified Quality Auditor (CQA).
-People management experience.
