New Position - Senior Regulatory Affairs Specialist

At ev3 we’re committed to developing innovative endovascular technologies for coronary, peripheral and neurological applications. Creative, competent people with a passion for enhancing healthcare around the globe have driven our success. Join us as we grow by making a meaningful difference.    We are currently seeking a Senior Regulatory Affairs Specialist.  This position is responsible for Planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets.  Ensure compliance with relevant FDA, MDD, ISO and other global regulations, for ev3 peripheral vascular products. Participate on internal development teams, providing US and/or International regulatory strategy and execution. Ability to lead and execute complex regulatory projects. Regulatory review of labeling and advertising, design changes, and specification changes. RESPONSIBILITIES: · Develop US and International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing · Assist in keeping company informed of regulatory requirements in the US · Participate on Product Development teams, providing regulatory strategy, timelines, and direction. · Prepare US submissions and International submissions. Work with FDA to obtain product approval/clearance · Ensure relevant ISO and FDA Export requirements are met, as required · Review Change Orders and assess regulatory impact of product changes on US and/or International regulatory strategy and submissions per standard procedures · Review labeling, training, promotional and advertising material · Evaluate post-market incident reports and determine MDR requirements · Support post market regulatory compliance activities for US/International product approvals · Develop and maintain regulatory affairs department procedures · Comply with applicable FDA and international regulatory laws/standards and the ev3Code of Conduct. · Other duties as assigned or required   This position is located at our manufacturing facility in Plymouth, MN.     We offer competitive compensation, generous benefits, and the opportunity to improve the lives of people everywhere. For consideration, please apply online at www.ev3.net. No phone calls please. Equal Opportunity Employer/ Affirmative Action Employer.



QUALIFICATIONS: · Bachelor’s degree in related field · Regulatory Affairs Certification (desired)   Experience:  · At least 5 years of US and International medical device regulatory submission/approval experience, to include FDA, MDD, MHLW, TGA, and TPP · 510(k), IDE and PMA experience (desired) · Knowledge of FDA, EU, MHLW, TGA, and TPP requirements     Other skills: · Strong communication skills · Strong technical writing skills