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Assistant General Counsel -- Regulatory Compliance
Refer job# IAHE169210
 
Assistant General Counsel -- Regulatory Compliance The candidate will be advising, counseling, and actively participating in the development of procedures, practices, and systems that ensure compliance with regulatory standards, with particular emphasis on the US FDA's quality system, medical device reporting, and corrections and removals regulations, the new European IVD regulation (IVDR), and international medical device standards, including ISO 13485 and ISO 14971. Providing counsel and advice to the company globally on regulatory and/or legal-regulatory issues with particular emphasis on FDA and other international regulatory authorities. Assisting in managing and responding to regulatory agency investigations and/or administrative actions. Actively participating as a standing member of the operating companies regulatory decision-making (e.g., field action and premarket notification) committees. Coordinating efforts across the operating companies and various business units to present a unified message to various regulatory bodies as well as quasi-regulatory non-governmental organizations (e.g., the WHO). Monitoring and tracking proposed healthcare-related regulations that will impact the company's businesses. Developing and presenting plans to the appropriate governing bodies that result in modifications to existing or proposed regulations that allow for the operating companies to offer their complete array of products and services. Providing regulatory reviews and analyses of new business ventures or acquisitions. Should have a Law degree from an accredited law school with a strong academic record. Licensed to practice law in at least one jurisdiction in the United States. Must have 10+ years as a medical device/drug attorney with significant focus on quality systems, adverse event / vigilance reporting, and field actions / recalls. Strong knowledge of FDA and international medical device and in vitro diagnostics requirements, and submission / reporting processes. Solid working knowledge of legislative and regulatory processes with strong established relationships or contacts with relevant regulatory authorities. Demonstrated ability to lead an organization to appropriate decision-making. Leadership capability. Commitment to excellence. Experience in medical device and in vitro diagnostics quality, regulatory, clinical, and compliance matters. Law firm and/or in-house experience in a biotech, pharmaceutical, or medical device company. Excellent legal analysis and communication skills. Effective, concise, and articulate written and verbal skills. Extremely responsive and client-service oriented.
 
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