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• 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

Position Overview

Canon Healthcare Optics Research Laboratory in Cambridge, MA is seeking a Staff Regulatory Affairs (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.

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Responsibilities

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.

Qualifications

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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