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 up-to-date artificial intelligence systems. Use cases include acute and chronic remote automated monitoring (RAM), hospital at home deployments and distributed clinical trials.Job DescriptionWe areseekinga detail-oriented and self-driven Quality and Regulatory Specialist to support and strengthen our quality and regulatory processes within a regulated medical device environment.This role is ideal for a Quality Management professional who takes initiative,operatesindependently, and thrives in structured, standards-based environments. If you naturallyidentifygaps, ask thoughtful questions, and take ownership of documentation accuracy and process alignment, you will excel in this role.You will work closely with cross-functional teams tomaintaincontrolled documentation, support compliance with applicable standards,assistwith gap assessments, and contribute to continuous improvement initiatives. The ideal candidate is highly organized,confidentnavigating ISO requirements, and comfortable working witha high levelof precision and accountability. Experience working within ISO regulated environments, particularly ISO 13485 is required. The role is hands-on and requires onsite work in Kitchener,



Ontario.What You'll DoSupport 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 forensuring that QMS processes and documentation conform to applicable standardsrequiredfor regulatory approval (Health Canada, FDA, CE)Administer andassistin the development of standards and workflows within the QMSInterface with the R&D team to ensure that PDLC processes and design principles fulfillanticipatedregulatory requirementsPerform gap analysis between existing processes and documentation and manage the updating processSupport internal and external audits.Assess compliance with standards and regulations andidentifyremedial actions where necessaryInterface with Ethical Research Boards andparticipatingacademic or health institutions during studies and trialsWho You Are5+ years of experience working within a regulated quality environment, preferably in medical device development and commercializationBachelor's degree in engineering with P.Eng. designationPractical experiencemaintainingor supporting a Quality Management SystemWorking knowledge of ISO 13485 and or ISO 9001 requirementsStrong documentation control and process organization skillsDemonstrated ability to work independently and drive tasks through to completionStrong attention to detail with the ability toidentifyinconsistencies or gaps in documentationClear written and verbal communication skillsComfortable collaborating with technical teams in a structured environmentJob Location

📌 Quality And Regulatory Specialist (Kitchener)
🏢 Cloud DX
📍 Kitchener