PASCALL Systems is a Cambridge‑based medical device company advancing EEG‑based anesthesia monitoring. We seek a Regulatory Affairs qualified 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
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📌 Regulatory Affairs Lead, Medical Devices (FDA/CE) | Hybrid (Winnipeg)
🏢 Pascall Systems
📍 Winnipeg
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