Description
Join this fast growing In-Vitro Diagnostics start-up company and lead their regulatory affairs team toward additional international and domestic submissions.Required Skills:- Experience with 510(K) - IVD- Experience negotiating with FDA and/or international health agencies- International IVD experience (IVDD experience a huge plus)- 5+ Years Regulatory Affairs Experience Desired Skills:- Cardiovascular / Biomarker experience- IDE experience a plus Day to Day Responsibilities:- Working on 510(K) submissions for expanded claims- Design history review- Writing/submitting Technical Files- Meeting with core teamsCultural fit:- Easy going demeanor- Thick Skin (will have to have tough discussions with board of directors from time to time)- Self-motivatedTo find out more about Real please visit www.realstaffing.com