REGULATORY AFFAIRS SPECIALIST

Beckman Coulter, Inc. is a leading manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum- from pioneering medical research and clinical trials to laboratory diagnostics and point-of-care testing- Beckman Coulter's 200,000 installed systems provide essential biomedical information to enhance health care around the world.Beckman Coulter is in the business of "Innovating Processes for Biomedical analysis." In addition to meeting customer needs with high quality, state-of-the-art instrument systems, the company develops collaborative relationships to help customers to identify ways to maximize the efficiency of those systems in their processes. This is referred to as The Power of Process. Why not consider becoming a part of a company that makes a difference in saving and improving the quality of lives around the worldResponsibilities:? Implements, facilitates, and reports on Beckman Coulter regulatory programs? Implements pre-market activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, and fulfilling regulatory compliance obligations? Prepares and maintains regulatory reports and listings? Acts as a team expert for promotional materials review, experimental designs, data analysis and product labeling as they relate to registration and commercialization of medical devices.General Expectations:? Normally receives no instruction on routine work; general instructions on new? assignments? Follows standard practices and procedures in analyzing data from which answers can be readily obtained? Handles problems of moderate scope where analysis of situations or data requires a? review of identifiable factors? Adheres to policies and proceduresQualifications:? Bachelor?s degree in sciences or technical field and 3 years of relevant experience or a Masters degree and 2 years of relevant experience or PhD and 21years of relevant experience.? Work experience with medical devices and/or in-vitro diagnostic fields? Ability to prioritize assigned work ? Ability to learn regulatory procedures ? Ability to communicate accurately with internal and external contacts? Ability to work with team members to resolve problems and achieve goalsIf you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com http://recruiter.kenexa.com/bci/cc/CCJobDetailAction.ss?command=CCViewDetail&ccid=bupJEdUjsTs%3D&job_REQUISITION_NUMBER=39996