Regulatory Affairs and Quality Systems Manager

Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean (excluding Mexico) markets.

Virtual Imaging, Inc. is currently seeking a Manager of Regulatory Affairs and Quality Systems to establish and maintain procedures and techniques for quality systems standards to ensure quality levels are maintained for FDA Quality System Regulation (QSR): responsible for complaint handling, CAPA (Corrective Actions and Preventive Actions) and MDR (Medical Device Reporting) to the FDA. Conducts quality audits. Conduct Quality Management Review meetings. Responsibilities will also include managing labeling approvals abd document control as well as management of FDA Pre-market Notification (PMN) for the products developed by the division. This role will be responsible for taking initiative to implement Canon's global Quality Management System (QMS) for the division.

* Works with senior management to develop regulatory strategies for FDA approvals. Directs the division's FDA regulatory activities and initiative, assures the quality of its records and products and ensures timely submissions, reports and filings to meet FDA's regulatory requirements. * Manages the Quality Systems Specialist position to ensure quality system compliance with all state and federal regulations, to include the hiring process and performance appraisal. * Responsible for regulatory guidance to the division's product development teams. * Responsible for regulatory submissions of FDA pre-market notification and 510(k). * Responsible for regulatory reports of MDR (Medical Device Reporting) and Baseline Reporting to the FDA. * Monitors and audits GMP (Good Manufacturing Practice) and cGMP (current GMP) policy and procedures. * Maintains correspondence and other records of all interactions with the FDA CDRH, FDA LA District Office and State of California - Health and Human Services. Coordinates and direct strategy and conduct all meetings with the FDA, and regular interaction with the FDA.

* Requires a bachelor's degree in a relevant field or equivalent experience. * Minimum of 7 years of relevant industry experience. * This position requires superior verbal and written communication skills and negotiating skills, and the ability to ensure that the division adheres to the FDA quality and regulatory guidelines.