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Job #03188

About our client Our client is a medical device company based in Minnesota. They design, develop and manufacture imaging systems for vascular angiography procedures. Over 2000 of their systems are installed worldwide and more than 4 million people have had cardiovascular angiographic procedures using their system. The company has marketed products, an experienced management team and an empowering corporate culture that is focused on the professional development of its employees. This is a great opportunity for the right candidate. Position Location Regulatory Affairs Specialist Eden Prairie, Minnesota Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop and implement global regulatory registration and support strategies for products throughout their life cycle 2) Perform device classification/predicate device search as well as global regulatory standard search and management 3) Develop product modification/line extension strategies and manage product development 4) Perform proactive data and information collection from internal and external sources to provide early warning feedback of actual/potential quality problems directly/indirectly involving company devices 5) Support global vigilance reporting 6) Provide regulatory expertise and guidance for compliance with current regulatory practices 7) Obtain timely regulatory approvals worldwide to include 510(k)s, PMAs, EC Marking and rest of world registrations to established requirement for the company 8) Manage regulatory communications and interaction (as directed) 9) Support import/export requirements and management 10) Define regulatory affairs and regulatory compliance strategies 11) Establish procedures for obtaining product approvals and for maintaining compliance with applicable laws, regulations and standards 12) Define submission type and submission content for new products or product modifications 13) Direct and participate in the preparation and submission of regulatory applications 14) Prepare responses to regulatory agencies requests for additional information to support submissions or post market surveillance activities 15) Liaise with regulatory agencies and officials to ensure the expeditious review and approval of applications 16) Prepare marketing license renewal applications 17) Maintain a working knowledge of changes in the global regulatory environment 18) Perform device listing and establishment registration including annual registration notifications 19) Determine regulatory submission or notification requirements for all changes to products throughout their life cycle 20) Review and approval of change orders for compliance with regulatory requirements 21) Prepare File/No-File evaluations for proposed device modifications 22) Review and sign-off on MRB ‘Use As Is’ dispositions 23) Participate in panel and regulatory meeting (as necessary) 24) Assist with preparing investigational plans and IDE applications (as required) 25) Review and approval of market acceptance protocols 26) Monitor/report on the post-approval enforcement activities of regulatory agencies 27) Review and approve labeling/advertising Requirements 1) BA in Science or Engineering or a combination of education and experience providing equivalent knowledge 2) 7 – 10 years of experience in regulatory affairs and quality management in the medical device industry with FDA class II and Class III products 3) Familiarity with information services applications and database management programs 4) Excellent track record with premarket regulatory applications and post-market compliance 5) Proficiency in designing and implementing quality systems and quality cost schemes 6) Excellent communication skills (oral and written) 7) Superb strategic and tactical planning and interpersonal/management skills 8) Proficiency in navigating FDA and foreign regulatory schemes 9) Ability to work (hands-on) with multiple projects and priorities 10) Ability to work in a deadline-sensitive, fast-paced business environment and in many high-stress situations 11) Willingness and ability to travel moderately (domestic and international)