A Black Diamond client who produces an IVD device is seeking two (2) complaint handlers to work on their revamped complaint system. They anticipate 19,000 complaints over the next year due to the new way that they classify and handle complaints. This will be mostly FDA based.
Reviewing, investigating and closing complaints.
Deciding if an MDR needs to be filed with the FDA.
Assist with the MDR as needed.
Must have a strong Medical Device background with an emphasis on complaint investigations.
Must have at least 1-2 projects with Invitro Diagnostic Devices, along with a strong technical writing background.
Need to have advanced excel and word experience in addition to TrackWise.
Experience with Veeva Vault is a plus.
5+ years experience with a degree preferred but experience is more important.