• Quality Internal Auditor: must have at least 5 years internal auditing experience to ISO 13485, FDA’s QSRs. Must be ISO 13485 Lead Auditor accredited.
  
  
• Clinical Monitor: must have at least 5 years experience clinical monitoring, familiar with IDE regulations
  
  
• Regulatory Associate: must have 5 years experience in Regulatory submissions (IDE, PMA, 510(k), design dossier, technical files