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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Accuray, Inc. in Sunnyvale, CA seeks Global Audit Manager. Understands various international quality assurance standards, governmental regulations, directives, and guidance, and then can auditing a biomedical device system, so as to ensure that the devise and its recommended use will comply with all these various regulatory standards around the world. 30% of reimbursed travel is required to company locations in Japan, China, Europe, and within the U.S. Mail resume to Accuray Inc., Attn: Stephanie Ogawa, 1310 Chesapeake Terrace, Sunnyvale, CA 94089. Must ref job code 64931. EOE.