About the company
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.
Responsibilities
- 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.
Conditions
- 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.