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Medical Device Regulatory jobs in Vancouver, BC

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    • Experience with software as a medical device, AI-based healthcare tools, or dental/medical technology is an asset.
    • View all Dentixion group ltd jobs - North Vancouver jobs
    • Salary Search: Regulatory Affairs Specialist salaries
    • Serves as a technical resource to support sales of a specific medical product or solution.
    • Supports field personnel in providing the best possible outcomes and…
    • Background in life sciences, pharmaceutical, or medical device sectors, advantageous.
    • 0-2 years of experience in Quality Management Systems or a related field…
    • Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over…
    • Prior experience in Regulatory Affairs, Quality, or Engineering in a regulated medical device environment.
    • Maintain clear, audit-ready regulatory rationales and…
    • Support interactions with regulatory authorities and ethics committees.
    • Provide medical input into lifecycle planning and early market preparation.
    • This is a pivotal and exciting time in our journey to bring this ground-breaking technology to patients!
    • As a member of the Manufacturing team, the Equipment…
    • Perform and document technical investigations into product feedback and complaints involving medical devices.
    • Minimum 5 years’ experience in software, systems,…
    • We are seeking an Equipment Technologist who will be responsible for fabricating equipment, assisting in equipment troubleshooting and repairing equipment used…
    • As a Continuous Improvement Engineer, you will lead cross-functional projects from initiation to completion and track project metrics to project targets.
    • 3+ years of QA experience in biotech or medical device manufacturing.
    • Morning shifts starting at 7:00 AM, evening shifts wrapping up around 7:30 PM, and…
    • 3+ years of QA experience in biotech or medical device manufacturing.
    • Review verification and validation documentation, including but not limited to test plans…
    • 7+ years of supplier quality engineering experience in medical device manufacturing or regulated industry.
    • You will lead the investigation and resolution of…
    • Your hard work and diligence ensure that Kardium meets or exceeds delivery commitments to our customers.
    • Develop long range operating plans and strategies and…
    • Practical knowledge of medical device regulatory requirements and standards such as ISO 13485 and ISO 14971.
    • Understanding of technical mechanical concepts and…
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Job Post Details

Regulatory Affairs Specialist - job post

Dentixion group ltd
North Vancouver, BC V7P 3S1
$60,000 a year - Full-time

Job details

Pay

  • $60,000 a year

Job type

  • Full-time

Location

North Vancouver, BC V7P 3S1

Full job description

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

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