A Black Diamond Medical Device Client is looking for an experienced Regulatory Affairs consultant to be responsible for supporting the development, preparation and coordination of class III device submissions and approvals for their transfusion products. They are currently in the middle of writing an IDE with a deadline for submission of December 1st, 2020.
Individual should have experience tracking regulatory submission activities
Scientific background - biology, chemistry, etc.
Previous experience working cross functionally with the Clinical department as they discuss clinical trial protocols and trial designs.