Careers With Sonacare Medical
Senior Director of Quality Assurance and Regulatory Affairs
Indianapolis, IN
About SonaCare Medical:
SonaCare Medical is a world leader in minimally invasive focused ultrasound (HIFU) technologies. SonaCare Medical is committed to developing focused ultrasound related technologies that support precise and innovative procedures for the treatment of a range of medical conditions. SonaCare Medical, with its subsidiary Focus Surgery, Inc., designs and manufactures medical devices, including the following: Sonablate®, which has 510(K) clearance in the U.S. under a De Novo regulatory classification; Sonablate® 500, which has CE Marking and has obtained regulatory authorization in more than 49 countries outside the U.S.; Sonatherm® laparoscopic HIFU surgical ablation system, which has 510(K) clearance in the U.S., has CE Marking and has obtained regulatory authorization in more than 30 countries outside the U.S.
Summary:
The Sr. Director of Quality Assurance and Regulatory Affairs is responsible for designing, planning, implementing, directing and evaluating the Quality Management System to ensure compliance is maintained with all regulations and standards, regulated activities, USA 510(K) submissions and international product approvals and registrations.