Job Description :
5 plus years of Regulatory Affairs experience
3 years of experience in the medical device industry
Must have authored a 510(k)
Must have knowledge of and/or European/International regulations and standards
Experience in preparing regulatory submissions
Experience interacting with FDA and/or other regulatory agencies
Must work well in team environments
Must demonstrate leadership skills in team setting
Proven analytical abilities; Solid understanding of manufacturing and change control, and an awareness of regulatory trends