Principal Regulatory Affairs Specialist

Responsible for US, EU and Japan Regulatory Affairs activities for a class III, breakthrough mechanical circulatory support system filed under PMA, EU Design Dossier(s) and Japanese Shonin. This includes the writing and submission of major regulatory submissions, directing and coordinating Regulatory Affairs consultants, establishing project priorities, providing technical guidance, and overseeing preparation of applications and maintenance of regulatory documentation. The role includes ensuring compliance of device labeling and supporting an environment of continuous improvement.