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Senior Regulatory Affairs Specialist
Ref No.: 18-49533
Location: Salt Lake City, Utah
Position Type:Direct Placement
Start Date: 07/16/2018
Senior Regulatory Affairs Specialist
Salt Lake City, UT
Fulltime Permanent

Required Skills:
Min 8 years of Regulatory Affairs experience
Min 8 years of experience in the medical device industry
Engineering Background Required: Min BS in Engineering, MS preferred
Must have authored a 510(k)
Solid Understanding of US FDA and EU MDR, EU regulations and standards
Experience in preparing regulatory submissions
Experience interacting with FDA and/or other regulatory agencies/ notified bodies
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