About this opportunity
KARDION lists this Hybrid Senior Regulatory Affairs Leader - FDA Submissions opportunity in irvine, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
A clinical stage startup in Irvine, CA is seeking a Principal Regulatory Affairs Specialist to lead the execution of key U.S. FDA submissions for Class III cardiovascular medical devices. The role involves developing regulatory strategies, partnering with cross-functional teams, and guiding submissions with minimal oversight. Candidates should have extensive regulatory experience and strong communication skills to thrive in a dynamic environment.
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Worksite address
irvine, CA, 92713, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.