Quality and Regulatory Specialist

We are seeking a detail-oriented and self-driven Quality and Regulatory Specialist to support and strengthen our quality and regulatory processes within a regulated medical device environment.

You will work closely with cross-functional teams to maintain controlled documentation, support compliance with applicable standards, assist with gap assessments, and contribute to continuous improvement initiatives.

Experience working within ISO regulated environments, particularly ISO 13485 is required.

Support communications with relevant regulatory bodies in North America and the EU to support clinical trials and device licensing/clearance.

Maintain internal quality processes, including shipping/receiving, incoming inspections, device assembly, and product releases.

Be responsible for ensuring that QMS processes and documentation conform to applicable standards required for regulatory approval (Health Canada, FDA, CE)

Vitaliti Technologies Inc. is creating an ecosystem of unique, proprietary medical devices and software that generate high frequency biological signals, feeding large volumes of structured data to our own machine learning & deep learning models. The key Vitaliti differentiator is the ability to gather very accurate telemetry from easy to use, continuous and spot monitor devices that can immediately be analyzed by modern artificial intelligence systems. Use cases include acute and chronic remote automated monitoring (RAM), hospital at home deployments and distributed clinical trials.