- 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 the clients’ 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
Our client 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. They are 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. They are currently seeking a Regulatory Affairs Advisor for their Cambridge, MA location.
- 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.