A BDN client is looking for a Regulatory Affairs Consultant who has PMA/IDE experience and who has worked in clinical trials. This is for an early feasibility study which will help this client lock down the design, ensure the device is safe in humans and will get approval to move forward. The client would like this to define the process for deliverables so the engineers know what they need to be successful. This individual should have lot release or Hematology Pump experience to be eligible for this position. Skills for this position include Regulatory Affairs, Early Feasibility Studies, and Medical Device experience preferably with hematology pumps. A Bachelor's Degree is preferred for this role.