PASCALL Systems is a Cambridge‑based medical device company advancing EEG‑based anesthesia monitoring. We seek a Regulatory Affairs skilled 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
📌 Regulatory Affairs Lead, Medical Devices Fda/ce Hybrid Winnipeg
🏢 Pascall Systems
📍 Winnipeg
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