Regulatory Affairs Lead, Medical Devices

19 hours ago

Kelowna, Canada Pascall Systems, Inc. Full-time €155,000 - €254,000/year
PASCALL Systems is a Cambridge‑based medical device company advancing EEG‑based anesthesia monitoring. We seek a Regulatory Affairs professional to translate product strategy into regulatory strategy, maintain submissions, and ensure alignment with FDA and international standards. The role requires independent judgment in a small team and cross‑functional collaboration. Responsibilities include defining regulatory strategies with the CEO, preparing 510(k) materials, and supporting clinical