Global Regulatory Affairs Lead, Medical Devices & Submissions

Katalyst CRO is seeking a Regulatory Affairs professional based in Irvine, California. The role involves leading regulatory strategies, product submissions, and managing a skilled team to ensure compliance in key markets including the USA and EU. Candidates should have a Bachelor's or Master's in a relevant scientific field and 5 years of experience in medical device regulatory affairs. Strong communication skills and the ability to navigate regulatory environments are essential. Experience with FDA submissions is preferred.
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