The manager is looking for someone to come in and work on the PMA submission and CE Marks. This consultant should have a heavy regulatory background with at least 5-10 PMA 180 day supplement submission under their belt.
Day to Day:
They will be reviewing technical documents, work off the outline to be able to tell a story to the FDA. Making sure they understand the PMA. Formulating the write structure, explain the need reference the correct technical documents/guidance documents. This person will also be working on changes to MRI and external electronic assembly.