Senior Regulatory Affairs Specialist

PASCALL SYSTEMS INC. • Cambridge, MA, US • published 2026-09-21 22:42:50.122231

Description

**Position Summary** PASCALL is a growing multidisciplinary medical device company building an FDA\-cleared, EEG\-based brain state monitoring platform — a wearable EEG sensor paired with an Android tablet application — now in active clinical use. As our platform matures, we are hiring a Regulatory Affairs professional to help guide our product, quality, and clinical plans through the regulatory pathways that support safe, effective, and compliant medical device development. This is a hands\-on role based in Cambridge, working closely with our CEO, regulatory consultants, quality assurance and product teams. You will help translate product strategy into regulatory strategy, prepare and maintain regulatory submissions and documentation, support design\-control and risk\-management activities, and ensure that our evolving platform remains aligned with FDA expectations and applicable international standards. Because the team is small and the roadmap is still being written, this role requires both regulatory rigor and practical judgment. We are looking for someone who can operate independently, clarify ambiguity, and help the company make smart, risk\-based decisions that support patie...

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