Quality and Regulatory Specialist

Company DescriptionVitaliti 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.Job DescriptionWe 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.This role is ideal for a Quality Management professional who takes initiative, operates independently, and thrives in structured, standards-based environments. If you naturally identify gaps, 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 to maintain controlled documentation, support compliance with applicable standards, assist with gap assessments, and contribute to continuous improvement initiatives. The ideal candidate is highly organized, confident navigating ISO requirements, and comfortable working with a high level of 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 Do 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) Administer and assist in the development of standards and workflows within the QMS Interface with the R&D team to ensure that PDLC processes and design principles fulfill anticipated regulatory requirements Perform gap analysis between existing processes and documentation and manage the updating process Support internal and external audits.Assess compliance with standards and regulations and identify remedial actions where necessary Interface with Ethical Research Boards and participating academic or health institutions during studies and trials Who You Are 5+ years of experience working within a regulated quality environment, preferably in medical device development and commercialization Bachelor’s degree in engineering with P.Eng. designationPractical experience maintaining or supporting a Quality Management System Working knowledge of ISO 13485 and or ISO 9001 requirements Strong documentation control and process organization skills Demonstrated ability to work independently and drive tasks through to completion Strong attention to detail with the ability to identify inconsistencies or gaps in documentation Clear written and verbal communication skills Comfortable collaborating with technical teams in a structured environment

Maintain and strengthen quality and regulatory processes to ensure compliance with Health Canada, FDA, and CE standards. Support clinical trials, manage QMS documentation, and collaborate with R&D to align design principles with regulatory requirements.

Requires a Bachelor's degree in engineering with a P.Eng. designation and over 5 years of experience in a regulated quality environment. Must have practical experience with ISO 13485 and strong skills in documentation control and gap analysis.

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Quality Management System
• ISO 13485
• ISO 9001
• Regulatory Compliance
• Gap Analysis
• Documentation Control
• Internal Auditing
• Medical Device Licensing
• Product Development Life Cycle
• Health Canada Regulations
• FDA Regulations
• CE Marking
• Technical Communication
• Process Organization
• Clinical Trial Support
• Engineering

• Healthcare
• Engineering
• Manufacturing
• Science & Research
• Management & Leadership

Formation minimale

Diplôme professionnel

Expérience minimale

5+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine