Corporate Regulatory Compliance Manager
Aluminaid Inc. - Santa Monica, CA

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A regulatory affairs director ensures that a corporation's controls and guidelines in compliance mechanisms are adequate, effective and in conformity with industry practices and governmental regulations. A control is a set of instructions that a compliance director puts into place to avoid losses due to employee error or neglect. A control is adequate when it indicates clearly how to perform tasks and make real-time decisions while work is in progress. An effective control provides accurate solutions to control breakdowns.

Serve as a key medical device/combination products risk management expert for the Corporate Quality Risk Management team and Corporate Quality Functions supporting device development and manufacturing. Provide leadership and subject matter expertise for the successful sustainment of a comprehensive device risk management program across Operations in compliance with ISO 9001, ISO 13485 requirements. Responsible for the device risk management process of assessment (identification, analysis and evaluation), mitigation (reduction, acceptance, communication) and review of risk during device development and manufacturing. Program develop