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Medical Devices & Diagnostics Global Services, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Medical Safety Officer supporting Biosense Webster, Inc. (BWI), located in Irvine, CA.
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The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
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The Medical Safety Officer (MSO) role will have primary responsibility for Biosense Webster, Inc. (BWI) and will provide medical safety stewardship for Medical Device (MD) products. Although a medically independent voice is key, collaboration in assessing potential safety signals is expected. This individual will be an active member of a diverse team, and a close partner with the quality leader and statistical colleagues, in assessing any potential safety signal for an MD product. Execute on the Medical Safety Organization’s strategy, by implementing programs and leading in the strategic priority areas as defined by the Chief Medical Officer (CMO).
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The MSO will build clear and positive relationships between R&D, Quality, Regulatory, Clinical, Epidemiology and Safety sciences and Safety process and groups to allow for proactive and flexible risk management system. Serve as a subject matter authority in the therapeutic area and patient risk management throughout the product lifecycle, from new product development, to launch and commercial life.
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The MSO will play a pivotal role in evaluating customer/user risk and in assessing the actual or potential impact of product performance issues on patient safety. The reactive elements of the role (addressing Quality/performance issues) are balanced with the need for a proactive approach in continually assessing all available information/data sources and advising on any mitigating activities, which should be taken to minimize potential risk to patients. Further, the MSO must be a trusted partner in the innovation process, engaging with R&D and quality engineering to drive Medical Devices and Diagnostics (MD&D’s) patient-centered innovation process.
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Interested candidates should follow the link below. Questions about the role? Contact Vincent Thomas at vthoma17@its.jnj.com.
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2105989690W - Medical Safety Officer
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Vincent C. Thomas, MD, MHA
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Biosense Webster-Johnson & Johnson
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31 Technology Drive, Suite 200
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