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SaMD Quality & Regulatory Affairs Specialist - Ottawa

Celestrahealth | ottawa, Canada | Posted June 19, 2026

Position Overview

A leading medical technology startup in Ottawa is seeking a Quality System and Regulatory Affairs Specialist to manage compliance with FDA and EU MDR regulations. The role involves supporting the Quality Management System, coordinating with teams for regulatory submissions, and ensuring the product meets legal standards. Ideal candidates will have a degree in Life Sciences and experience in medical device regulations, particularly Software as a Medical Device (SaMD). This is an onsite position offering a competitive salary and opportunities for growth.
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