Regulatory Specialist – AI/ML Projects

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Specialist – AI/ML Projects based in Canada.

This is a specialized regulatory role supporting the development and commercialization of AI/ML-enabled medical devices. You will work at the intersection of regulatory affairs, data science, machine learning, and medical device development. Your expertise will help translate complex AI/ML methodologies into clear, accurate, and audit-ready regulatory documentation. You will contribute to regulatory strategies and submissions across major markets, including Canada, the United States, and Europe. The role offers the opportunity to influence how innovative medical imaging technologies progress through development and regulatory review. This is a highly collaborative environment where precision, scientific understanding, and strong documentation practices are essential.

Accountabilities:: Collaborate with machine learning engineers and Regulatory Affairs teams to define and execute regulatory strategies for AI/ML-enabled medical device products.

Translate complex machine learning concepts, methodologies, and development processes into clear and precise regulatory documentation.

Maintain comprehensive documentation covering ML algorithms, datasets, model performance metrics, training methodologies, and data preparation procedures.

Develop and maintain technical documentation related to AI/ML model verification and validation.

Support the preparation of technical sections for FDA 510(k) submissions and equivalent regulatory submissions in Canada and Europe.

Collaborate with Regulatory Affairs teams on technical regulatory documentation and Design History File (DHF) requirements.

Support documentation demonstrating compliance with applicable medical device, software, quality, risk management, and usability requirements.

Maintain robust version control and document change management processes throughout the product lifecycle.

Contribute to the development and execution of regulatory strategies for AI/ML products as technologies and regulatory expectations evolve.

Work cross-functionally with R&D, Data Science, Regulatory Affairs, and other stakeholders to ensure regulatory requirements are incorporated effectively into product development.

Support regulatory documentation and activities related to clinical studies and associated processes when required.

Requirements:

Post-secondary education in a scientific or technical discipline, or equivalent relevant experience.

At least 5 years of experience working in a regulated industry, preferably medical technology, with direct experience supporting AI/ML-enabled products and regulatory submissions.

Strong interest in and practical understanding of machine learning concepts and processes involved in the design and development of AI/ML-enabled medical devices.

Working knowledge of ISO 13485, IEC 62304, ISO 14971, IEC 62366, MDSAP, EU MDR, FDA, and Health Canada requirements applicable to medical devices, AI/ML technologies, and Software as a Medical Device (SaMD).

Understanding of quality management systems and software development lifecycle processes.

Experience preparing or supporting regulatory and technical documentation for complex software or medical device products.

Knowledge of clinical study requirements and related regulatory processes, including IDEs, ITAs, and IRB requirements.

Exceptional attention to detail and the ability to work within rigorous documentation and quality standards.

Strong analytical, strategic, and problem-solving abilities, with a structured and focused approach to complex regulatory challenges.

Excellent written and verbal communication skills, with the ability to explain technical concepts clearly to both technical and non-technical stakeholders.

Strong collaboration skills and experience working effectively across R&D, Data Science, Regulatory Affairs, and other cross-functional teams.

Excellent time-management and prioritization skills, with the ability to manage multiple deadlines in a fast-paced environment.

Self-motivated, adaptable, and comfortable taking ownership of projects and deliverables.

Benefits:

Salary range of $85,000–$105,000 CAD .

Two-year fixed-term contract.

Remote opportunity open to candidates across Canada.

Opportunity to work on high-impact AI/ML-enabled medical imaging technology.

Chance to contribute to solutions designed to make medical imaging more accessible worldwide.

Collaborative, innovative, and highly cross-functional working environment.

Opportunities to work closely with specialists across regulatory affairs, data science, machine learning, and R&D.

Modern workplace facilities, including sit/stand desks, health and wellness amenities, stocked kitchen, outdoor spaces, and on-site daycare.

Free on-site gym and enclosed parking.

Convenient access to public transportation.

Inclusive workplace committed to equal opportunity and accessibility.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1