Regulatory Affairs Lead – Medical Devices & Software

PASCALL Systems is seeking a Regulatory Affairs professional in Cambridge, MA to drive regulatory strategy and coordinate FDA/CE submissions for our EEG-based medical device platform. You will work closely with product, clinical, and quality teams to ensure design controls, risk management, and labeling align with FDA expectations.

Ideal candidates bring 4–6 years in regulated medical devices, strong writing skills, and the ability to balance risk with business needs in a small company