Senior Regulatory Specialist, AI/ML Projects

This is a fully remote position, open to applicants in Canada.

📋 Description

• Work collaboratively with ML engineers and Regulatory Affairs teams to establish and implement regulatory strategies for AI/ML products.

• Ensure meticulous and comprehensive documentation of ML algorithms, datasets, and performance metrics for regulatory assessment.

• Develop technical documentation that outlines AI/ML model training methodologies, data preparation processes, and model verification and validation procedures.

• Partner with Regulatory Affairs on the technical components of FDA 510(k) submissions and equivalent applications, including those for Health Canada and EU MDR.

• Collaborate with Regulatory Affairs to meet regulatory technical documentation and DHF documentation requirements.

• Oversee version control and document change management processes.

• Simplify intricate machine learning concepts into clear and precise regulatory documents.

• Assist Data Science and Regulatory Affairs teams in formulating regulatory strategies for AI/ML-enabled medical devices.

⛳️ Requirements

• A degree in a scientific or technical discipline or equivalent experience.

• Over 5 years of experience in a regulated medical device setting.

• Direct involvement in pre-market submissions, including FDA 510(k) or equivalent, for AI/ML-enabled devices.

• Practical experience designing or conducting prospective clinical studies for AI/ML devices, encompassing IDE, ITA, and IRB pathways.

• Familiarity with FDA guidelines for AI/ML and SaMD, including classifications for CAD vs CDS.

• Capacity to independently lead regulatory strategy with minimal supervision.

• Knowledge of ISO 13485, IEC 62304, ISO 14971, IEC 62366, MDSAP, EU MDR, and FDA and Health Canada regulations for AI/ML-enabled devices.

• Understanding of quality management systems and the software development lifecycle.

• Proficiency in ML concepts, including training, performance metrics, and bias.

• Experience collaborating with data science and engineering teams.

• A keen interest in ML concepts and processes related to the design and development of AI/ML-enabled medical devices.

• Possess strategic thinking, collaboration skills, analytical abilities, focus, and self-motivation.

• Exceptional attention to detail and the ability to adhere to stringent documentation standards.

• Strong time-management abilities and the capability to prioritize tasks in a fast-paced environment.

• Excellent verbal and written communication skills.

• Effective collaboration with cross-functional teams, including R&D, Data Science, and Regulatory Affairs.

🏝️ Benefits

• Fixed-term contract of two years.

• Modern office equipped with sit/stand desks.

• Access to health and wellness facilities.

• Fully stocked kitchen.

• Outdoor amenities available.

• On-site daycare services.

• Enclosed parking options.

• Complimentary on-site gym.

• Conveniently located near a SkyTrain station.

• Recognized as a Great Place to Work-certified employer.

• Focus on employee well-being.

• Committed to being an equal opportunity employer.

• Interview accommodations are available upon request.