Senior Regulatory Affairs Lead - Medical Devices (510(k)/EU MDR)

LHH is seeking a Senior Regulatory Affairs Specialist in Dublin, California to support global regulatory strategies for medical devices. The role involves preparing submissions, leading communications with regulatory agencies, and ensuring compliance with evolving regulations.

The ideal candidate has over 8 years of experience in regulatory affairs, particularly with FDA 510(k) and EU MDR submissions. Strong project management and technical writing skills are essential.