Global Regulatory Submissions Lead

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katalyst croCharlotte (NC)

Regulatory Affairs Managers Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

SENIORITY

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About the role

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.

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