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Job #03443

About our client Our client is a publicly traded medical device company headquartered in Texas that is focused on the development and commercialization of innovative therapies for neurological disorders.The company has an experienced management team, excellent momentum with their target market and have grown both revenue and profitability significantly during the past year. This is a unique opportunity for someone that wants to put their drive and initiative to work! Position Location Regulatory Affairs Specialist Houston TX Salary Highly competitive package, commensurate with experience Responsibilities 1) Preparing regulatory submissions (510(k); IDE; IDE Supplements; PMA; PMA Supplements, etc.) for submission to the FDA 2) Interfacing with the FDA on assigned projects 3) Responding to FDA requests for additional information 4) Keeping abreast of changes to the worldwide regulatory requirements and International Standards related to the company's products and processes 5) Formally communicating regulatory initiatives or changes in the applicable medical device laws with company personnel, customers, subcontractors, regulatory agency representatives, and third party organizations 6) Reviewing QSR documentation for assigned projects and proposed individual changes to insure compliance with the Company’s quality system procedures and determining whether regulatory submissions are required 7) Participate on the Compliance Review Board for the review and approval of promotional advertising and literature Requirements 1) Advanced degree in Engineering, Bioengineering, Life Science or related area 2) Class III implantable medical device experience, e.g. cardiovascular or Neurological pacemaker 3) RAC certification and familiarity with electronic submissions preferred 4) ISO 13485 experience a plus 5) Ability to speak a foreign language a plus but not required