Title	REGULATORY AFFAIRS ASSISTANT
Location	Southwest
Company	Fortune 100 Medical Manufacturing Company
Package	$38,000 - $63,000
Primary Accountabilities and Responsibilities                                                                 - Coordinates, compiles, and submits 510(k)   applications, PMA submissions, PMA supplements,   new drug applications and annual reports - Help prepare responses to FDA questions and other   regulatory correspondence - Assist in preparing outlines, summaries, status report   memos, graphs, charts, tables and slides as   necessary - Develop solutions to a variety of problems of moderate   scope complexity - Maintain the regulatory affairs filing system
Credentials / Knowledge / Skills Preferred                                                                 - Bachelor's degree, preferably scientific discipline   with 3 years experience or 2-5 years experience   in related technical area such as clinical   development, R&D labs or QA - 510(k) or PMA submission experience beneficial - Strong organizational and communicational skills - Requires general use and application of regulatory   concepts, practices and techniques - Computer literacy