Job - Quality System and Regulatory Affairs Specialist (Ottawa Based)

Job Application and Information for: Job - Quality System and Regulatory Affairs Specialist (Ottawa Based)

Position Overview

We are currently seeking a detail-oriented Quality System Associate/Specialist to join our team, who is also well-versed in EU MDR and FDA medical device regulations. This position includes the following responsibilities:

• Supporting the implementation, maintenance, and ongoing improvement of our Quality Management System (QMS), to ensure compliance with FDA QSR/QMSR and ISO 13485:2016, focusing on Software as a Medical Device (SaMD) products.
• To lead and coordinate the certification process for Software as a Medical Device (SaMD) in compliance with EU Medical Device Regulation (MDR), including the preparation of all required documentation. Responsibilities also extend to preparing submissions to the US FDA, building on our existing Class II SaMD designation.
• The candidate will work closely external Quality Sys...