Regulatory Affairs Specialist - Medical Device - Austin, TX

This position is open as of 5/8/2008. Are you a fit? Click Here to Apply Now! Job Details Regulatory Affairs Specialist - Medical Device - Austin, TX renderImage('http://www.cybercoders.com/images/search.png', 84, 39); Specifications Location   Austin, TX; San Antonio, TX Salary   $65,000 - $80,000 Education   Bachelor of Science Category   Pharmaceutical Experience Required   At least 2 Years Short Description   Regulatory Affairs Specialist - Medical Device - Austin, TX Required Skills   Regulatory Affairs, Medical Device, 510(k), ISO 13485, GMP, CE Marking Recruiter   David Wright Date Updated   5/8/2008 Job Description Skills Required Regulatory Affairs, Medical Device, 510(k), ISO 13485, GMP, CE Marking Job Description Regulatory Affairs Specialist - Medical Device - Austin, TXWe are one of the leading medical device regulatory firms with expertise in CE Marking, Good Manufacturing Practices (GMP), ISO 13485 quality system implementation, Canadian licensing, SFDA registration and many other areas. Specific Responsibilities:* Program management of medical device regulatory service programs, including Authorized Representation for Europe. * Provide ongoing assistance with regulatory compliance and/or quality assurance issues for medical device and IVD clients. * Handle client inquiries and provide phone consultation regarding medical device quality assurance and regulatory compliance issues from our client base of several hundred medical device companies. * Prepare FDA 510k applications and compile/review Technical Files for CE Marking. * Coordination of client Incident Reporting/Adverse Events. * Update and maintain client files.Requirements:* 3+ years of experience in the medical device sector in a regulatory compliance and/or quality assurance role. * Extensive knowledge of CE Marking and the Medical Device Directive. * Experience with FDA 510(k) and Technical File preparation. * Experience with Incident Reporting/Adverse Events and recalls. * Experience with implementation and maintenance of quality systems (ISO 13485 and FDA GMP). * International experience and understanding preferred. * RAC designation a plus. * Good computer and skills; inclination to adopt technology to maximize efficiency. * First-rate written communications skills. Excellent customer service and telephone skills. * Foreign languages a plus. Location: Austin, Texas; San Antonio, Texas Want to interview today? Click Here to Do a Quick 2-Minute Online Interview! Are you a fit for this position? Please Click Here to Apply! (your information will be kept strictly confidential!) Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also: Email your resume in Word to: David.Wright@CyberScientific.com **Please do NOT change the email subject line in any way. You must keep the JobID: CC MonsterAp : DW-TX-RAS1 -- in the email subject line for your application to be considered.*** David Wright - Senior Recruiter - CyberScientific   logET();PauseFooter(false);