Senior Regulatory Strategist, Medical Devices (CA)

BioRobotics in San Jose is seeking a Principal Regulatory Affairs Specialist to provide regulatory leadership throughout product development. The role demands a minimum of 12 years in the medical device sector and experience with regulatory submissions, including FDA 510K and CE Mark documentation.

The ideal candidate will possess a Bachelor’s degree in a scientific field, with a regulatory affairs certificate preferred. Responsibilities involve regulatory representation, managing project timelines, and ensuring compliance with international regulations.