Regulatory Affairs Lead, Medical Devices
19 hours ago
Kelowna, Canada
Pascall Systems, Inc.
Full-time
€155,000 - €254,000/year
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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