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Medical Device Principal Regulatory Affairs Specialist

Medical Device Principal Regulatory Affairs Specialist

Overview

Drive regulatory excellence at our Healthcare Optics Research Laboratory for our biomedical devices in collaboration with world-leading medical institutions. We are seeking an experienced Medical Device Principal Regulatory Affairs Specialist (Advisor, Regulatory Affairs) professional who will define and execute the regulatory plans to obtain and maintain regulatory approvals within the US and international markets.

 

Responsibilities

- 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
- Prepare regulatory assessments and plans for new products and design changes
- Preparation of regulatory submissions for product approval/clearance, including 510(k) premarket notifications
- Lead interactions with regulatory agencies needed to obtain product approval/clearance
- 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 Investigational Device Exemption submissions
- Support post-market regulatory compliance activities for US and international products

Qualifications

- BS or higher degree in engineering, science, health care or similar
- 10 years medical device experience, including demonstrated experience in preparing successful domestic and international submissions
- Experience in acting as a liaison to and communicating with regulatory agencies
- Strong working knowledge of FDA and EU (MDR) medical device regulatory requirements
- Knowledge of Japanese and other international regulations is a plus
- MDSAP experience is a plus
- RAC certification is a plus
- Proficient in Microsoft Office
- Must possess strong oral and written communication skills
The company will not pursue or support visa sponsorship for this position.

Company Overview

About our Company - 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 2018† and is one of Fortune Magazine's World's Most Admired Companies in 2019. 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 pr@cusa.canon.com.

† 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.

We are an EEO/AA employer. Minority/Female/Individuals with Disabilities/Protected Veterans.

If you are not reviewing this job posting on our Careers’ site https://www.usa.canon.com/internet/portal/us/home/about/careers, we cannot guarantee the validity of this posting. For a list of our current postings, please visit us at https://www.usa.canon.com/internet/portal/us/home/about/careers.

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