Regulatory Affairs Specialist
Company: Dentixion Group Ltd.Location: North Vancouver, BCJob Type: Full-timeNOC: 4264Salary: $60,000 per yearReports to: Chief Operating Officer
About Dentixion
Dentixion Group Ltd. is a Canadian healthtech company developing an AI-powered dental software platform for modern dental practices. The platform is being built to support dental diagnostics, treatment planning, patient communication, and professional training through AI, VR/AR visualization, and secure cloud-based workflows.
Dentixion is currently in its first-year development and regulatory-readiness phase. The company is focused on refining its early platform modules, preparing for pilot validation, and building the documentation required for future clinical and commercial deployment.
Position Summary
Dentixion is seeking a Regulatory Affairs Specialist to support the company’s licensing, compliance, and regulatory documentation activities. This role is well suited for someone who is detail-oriented, organized, and comfortable working in a health technology environment where product development, privacy, quality systems, and regulatory planning need to move together.
The successful candidate will work closely with the COO, founding team, software team, and external advisors to help Dentixion prepare for Health Canada requirements, privacy compliance, and quality management processes.
Key Responsibilities
- Support the classification of Dentixion’s AI, VR, and AR software features under applicable Canadian medical device requirements. Assist with Health Canada documentation, including technical files, risk assessments, evidence summaries, and submission-related materials. Support privacy and data protection work related to PIPEDA, secure data handling, patient consent, and clinical information workflows. Help organize documentation for quality management processes and ISO 13485 readiness. Maintain clear records of regulatory requirements, internal decisions, compliance tasks, and advisor feedback. Work with the product and development teams to ensure regulatory considerations are reflected during platform development. Monitor relevant healthcare technology, digital health, medical device, and privacy compliance requirements.
Required Qualifications
- Education or experience in regulatory affairs, healthcare compliance, life sciences, biomedical technology, public health, or a related field. Understanding of Canadian medical device regulations, Health Canada processes, or healthcare compliance standards. Familiarity with PIPEDA, healthcare privacy requirements, or digital health compliance is considered an asset. Strong research, writing, documentation, and organizational skills. Ability to work with clinical, technical, and business teams. High attention to detail and comfort working with regulated health technology products. Experience with software as a medical device, AI-based healthcare tools, or dental/medical technology is an asset.
Pay: $60,000.00 per year
Work Location: In person
