Global Regulatory Submissions Lead

Katalyst CRO is seeking a Regulatory Affairs professional to lead regulatory guidance for project teams and external partners in a fast-paced, global setting. You will coordinate submissions, engage with FDA and EU authorities, and mentor junior staff within the Global Regulatory department. The role requires at least 5 years in IVD Regulatory Affairs, expertise in 510(k) and PMA submissions, and strong communication skills to navigate cross-functional teams.