Sr. Manager, Regulatory Affairs

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. Devotes a significant portion of time to submission strategy, planning and writing. Responsibilities include planning, structuring, and completing major regulatory submissions including US IDE, PMA, EU Design Dossiers and Japanese Shonin; directing and coordinating activities of Supira’s Regulatory Affairs consultants; establishing project priorities; providing technical guidance; writing, reviewing, and editing submissions; overseeing preparation and submission of regulatory applications; reviewing device labeling for compliance; and supporting a continuous improvement work environment aligned with the Supira Quality Policy.