Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
4 Year Degree
Canon Healthcare Optics Research Laboratory in Cambridge, MA is seeking a Regulatory Affairs Advisor to drive regulatory excellence for our unique biomedical devices in collaboration with world-leading medical institutions. We are seeking an experienced Regulatory Affairs professional who will define and execute the regulatory plans to obtain and maintain regulatory approvals within the US and international markets.
Prepare regulatory assessments and plans for new products and design changes
Prepare or direct the preparation of regulatory submissions for product approval/clearance, including 510(k) premarket notifications. Participate in interactions with regulatory agencies needed to obtain product approval/clearance
Support Investigational Device Exemption submissions
Participate on product development Core Teams assisting with regulatory assessments and planning; reviewing product development and clinical protocols and reports to ensure collection of appropriate data for regulatory submissions; and participating in risk assessments and design reviews
Review labeling, training, and promotional materials for compliance with claims and applicable regulations
Assess product and manufacturing changes to determine regulatory impact
Provide ongoing surveillance and analysis of FDA and international medical device regulations for impact on Canon products and regulatory procedures. Communicate regulatory requirements to management, Core Teams and others; particularly new and revised regulatory requirements
Develop and maintain regulatory procedures and policies to ensure compliance to applicable regulations
Support US and international product registrations
Support post-market regulatory compliance activities for US and international products
Education: BS or higher degree in engineering, science, health care or similar required
Experience: 10+ years regulatory experience with at least 5 years regulatory experience in Medical Devices, including demonstrated experience in preparing successful FDA 510(k) submissions. Experience in preparing international submissions is a plus
Experience in acting as a liaison to and communicating with regulatory agencies
Strong working knowledge of FDA medical device regulatory requirements. Knowledge of MHLW, MDD, and other international regulations is a plus
RAC certification is a plus
Skills: Proficient in Microsoft Office
Must possess strong oral and written communication skills
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Internal Number: 7032
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About 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 markets. With approximately $36 billion in global revenue, its parent company, Canon Inc. (NYSE:CAJ), ranks third overall in U.S. patents granted in 2017† and is one of Fortune Magazine's World's Most Admired Companies in 2018. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based service and support for all of the products it distributes in the United States. 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 firstname.lastname@example.org.
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