Specialist, Regulatory Afairs/Quality Systems Associate – Canon – Melville, NY


Company Overview:
Virtual Imaging, Inc. is a wholly-owned subsidiary of Canon U.S.A., Inc.

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. With approximately $31 billion in global revenue, its parent company, Canon Inc. (NYSE: CAJ), ranks third overall in U.S. patents granted in 2014† and is one of Fortune Magazine’s World’s Most Admired Companies in 2015. In 2014, Canon U.S.A. has received the PCMag.com Readers’ Choice Award for Service and Reliability in the digital camera and printer categories for the 11th consecutive year. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based consumer service and support for all of the products it distributes. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company’s RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact pr@cusa.canon.com.

Canon U.S.A’s extensive product line and digital solutions enable businesses and consumers worldwide to capture, store and distribute information.

Virtual Imaging specializes in the sale, service, and maintenance of diagnostic imaging equipment for optimal patient care. Collaborating with large complex hospitals, government organizations, medical facilities, and security agencies, Virtual Imaging offers advanced digital radiography technology, such as diagnostic equipment, digital flat panel technology, and imaging solutions to improve overall workflow and efficiency. To learn more about the seamless synergy of Canon’s wide range of digital radiography and fluoroscopy solutions with Virtual Imaging’s leading RadPRO product portfolio and how they can meet the diverse needs of healthcare providers, please visit www.virtualimaging-fl.com/ or www.usa.canon.com/cusa/healthcare/products/digital_radiography.

† Based on weekly patent counts issued by United States Patent and Trademark Office.

All referenced product names, and other marks, are trademarks of their respective owners.

Canon is proud to be an equal opportunity employer. Minority/Female/Individuals with Disabilities/Protected Veterans. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status, or any other characteristic protected by law. To read more about employment discrimination protections under federal law, please visit this site: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf

Position Overview:
Establish and manage all aspects of Document Control activities. Ensures compliance with labeling requirements and Design Control documentation. Supports and/or conducts specialized audits for department activities.

Responsibilities:
Manage all aspects of Document Control Provides regulatory expertise in regulatory labeling requirements. Ensure that all Design History projects comply with regulatory, developer, and company requirements for HS products. Provide regulatory and compliance interpretations to Marketing and Sales on labeling issues Assists in training staff on pertinent regulatory and pertinent issues, as assigned by department senior staff. Topics include inspections, document compliance, etc. Conducts and/or participates in specialized audits, i.e.: documentation, integration, CAPA, procedure manuals, labeling, etc. Coordinates department annual records retention projects to ensure compliance with regulatory requirements Conducts product inspections, i.e.: receiving and integration with department administrative staff Participates in CINC Compliance meetings Participates in company Quality Management Review meetings Assists department and senior management and participates in regulatory investigations. Participation includes, but is not limited to: answering questions on documentation, taking inspection notes with Inspection Coordinator, identification of relevant inspection documents, etc. Assists with Complaint integrations into Complaint database Initiates and/or assists with trending of documentation metrics for company Management Review and additional meeting forums

Qualifications:
Education: Bachelor’s required. Preferably in science or healthcare discipline. Experience Required: 0-2 years in a medical/pharmaceutical company preferably with responsibility for documentation compliance Excellent understanding of documentation (good documentation practices) required in a medical device/pharmaceutical environment Excellent communication skills, both orally and in writing Experience interfacing with regulatory agencies, i.e., FDA is highly desirable Ability to provide routine trending on documentation projects, as required



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