Manager / Sr. Manager, Regulatory Affairs

This role serves as a key member of the cross-functional team, partnering with Clinical, Quality, R&D, and Executive Leadership to support U.S. regulatory activities and lead global clinical studies. The position involves developing regulatory strategies for thrombectomy and catheter-based cardiovascular technologies, managing FDA submissions, and expanding into international markets. The ideal candidate will leverage strong FDA medical device experience and hands-on knowledge of international regulatory pathways to support global commercialization efforts.