nnJob DescriptionnJob DescriptionnnOur client is a rapidly expanding Medical Device company looking to add some exceptional talent to their organization. nWe are seeking a hands-on Senior Regulatory Affairs Specialist/Manager (depending on the level of experience our client is open to both titles) to support the Company’s regulatory activities across a variety of programs.nnThe Senior Regulatory Affairs Specialist combines knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation and regulations. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain data and ensure that they are effectively presented for the registration of products worldwide. The initial role of the Senior Regulatory Affairs Specialist will be as an individual contributor.nThe Senior Regulatory Affairs Specialist should also have sufficient experience in regulatory compliance to provide direction and guidance to R&D, manufacturing, marketing/sales to changing regulatory requirements and standards.nThis position reports to the Senior Director of Quality Assurance and Regulatory Compliance.nThe ideal candidate would have had previous medical device experience and looking for potential for growth.nnESSENTIAL DUTIES AND RESPONSIBILITIES nnnAssist with the acceptability of quality, preclinical and clinical documentation for submission filingnAssist in writing, preparing, and managing regulatory submissions and filings required for U.S. FDA and other international authorities (i.e. 510(k), CE Marking, Health Canada License, etc.)Evaluate changes to existing products for impact on global regulatory affairs submissions.nCompile, prepare, review and submit regulatory submission to authoritiesnMonitor impact of changing regulations on submission strategies and update internal stakeholdersnMonitor applications under regulatory reviewnMonitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authoritiesnEvaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategiesnProvide input on technical guidance and regulatory requirements to communicate with internal teamsnWorking with the Senior Director of RA/QA manage and execute preapproval compliance activitiesnSupport product development teams with regards to implementation of international regulatory requirements.nnPost marketnnOversee processes involved with maintaining annual licenses, registrations, listingsnWorking with the Senior Director of RA/QA ensure compliance with product post marketing approval requirementsnWorking with the Senior Director of RA/QA Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agenciesnWorking with the Senior Director of RA/QA report adverse events to regulatory agencies and internal stakeholdersnWorking with the Senior Director of RA/QA Provide regulatory input for product recalls and recall communicationsnMaintain and update regulatory affairs procedures and changesnHelp with continuous improvement of the submission process.nnnnnJob RequirementsnEDUCATION and/or EXPERIENCEnQualifications / Skills RequirednnnBachelor’s degree in a scientific discipline; advanced degree and RAC (Regulatory Affairs Certificate) preferrednFive or more years’ experience in regulatory affairs with direct project management responsibilitiesnExperience in assisting the development, writing and submittal of successful IDE/510(k)/PMA/De Novo submissionsnMust have prior working experience with application processes for 510ks, Health Canada Application and CE Mark technical filesnWorking knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and 21 CFR 820.nKnowledge of software development and software quality as it relates to regulatory submissions a plus.nStrong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe AcrobatnExcellent organizational and negotiation skills as well as attention to detailnExcellent oral and written communication skillsnAbility to work independently as an individual contributor and in a team environmentnStrong attention to detailn nnFor immediate consideration, please submit a resume directly through this posting. PLEASE NOTE, ONLY CANDIDATES IN THE BAY AREA WILL BE CONSIDERED OR CANDIDATES IN THE STATE OF CA LOOKING TO RELOCATE TO THE BAY AREA AT THEIR OWN EXPENSE. SORRY, NO HIB VISAS OFFERED.