KARL STORZ United States is currently looking for a Product Safety & Vigilance Specialist. This role is responsible for identifying, assessing, communicating, and developing action plans to address real or theoretical product safety risks. In addition, this person ensures compliance with regulatory standards and guidelines, and corporate standard operating procedures as they relate to the global medical device reporting and complaint management; ensures clear and balanced communication and processing of potential MDRs, in collaboration with European Headquarters and other internal and external stakeholders, as subject matter expert; and provides guidance and advice and works with regulatory agencies.
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