Sr Regulatory Affairs Specialist

Division: Atrial Fibrillation Division (AFD) Location: Minnetonka, MN 55345 Status: Full Time, Employee Job Category: Manufacturing/Production/Operations Work Experience: 5+ to 7 Years Education Level: Bachelor's Degree Career Level:Experienced (Non-Manager) Company:St. Jude Medical Sr Regulatory Affairs Specialist Essential Functions: Plans, coordinates and compiles US/international regulatory submissions with minimal review with sign-off responsibility to obtain and sustain commercial approval.Participates on project teams providing appropriate information on regulatory issues and obtains needed information to meet regulation requirements.Reviews labeling for compliance with regulations and ensures that claims can be substantiated.Serves as regulatory liaison with FDA on behalf of the organization to facilitate timely and  favorable review of submissions and issues.Maintains current knowledge base on existing and emerging regulations, standards and guidance documents.Assists in reviewing new projects to determine the nature and scope of regulatory involvement; has responsibility for providing written regulatory strategies for new product ideas.Qualifications: The successful candidate will have a BS in engineering or the sciences with a minimum 5+ years of medical device regulatory experience.  The candidate should have both US and international experience with 510(k)s, IDE’s, PMA’s, Design Dossiers, Technical Files and other international registrations. Prefer Electrophysiology Experience.Qualified candidates may apply on our website at www.sjm.jobs.  Reference number AF11809.  St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.