Principal Regulatory Specialist – AI/ML Projects

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

📋 Description

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

• Convert intricate machine learning concepts into clear and concise regulatory documentation.

• Generate design history file (DHF) documentation.

• Prepare regulatory submissions along with associated data documentation.

• Keep thorough records of ML algorithms, datasets, and performance metrics for regulatory assessments.

• Develop technical documentation that details AI/ML model training methodologies and data preparation procedures.

• Produce documentation for model verification and validation.

• Work collaboratively with Regulatory Affairs on the technical aspects of FDA 510(k) submissions and their counterparts in Health Canada and EU MDR.

• Partner on regulatory technical documentation and DHF requirements.

• Manage version control and document change management processes.

• Collaborate with ML engineers, R&D, Data Science, and Regulatory Affairs teams.

⛳️ Requirements

• A post-secondary education in a scientific or technical discipline or equivalent experience.

• Over 5 years of experience in a regulated medical device environment or similar regulated industry.

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

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

• Familiarity with FDA guidelines regarding AI/ML and SaMD, including CAD versus CDS classification.

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

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

• Awareness of ML concepts, including training, performance metrics, and bias.

• Enthusiasm for ML concepts and processes related to the design and development of AI/ML-enabled medical devices.

• Experience working alongside data science and engineering teams.

• Capability to independently lead regulatory strategy with minimal oversight.

• Strategic, collaborative, analytical, focused, and self-driven.

• Exceptional attention to detail and proficiency in adhering to strict documentation standards.

• Strong time management abilities and skill in prioritizing tasks in a dynamic environment.

• Excellent verbal and written communication skills.

• Ability to effectively collaborate with cross-functional teams, including R&D, Data Science, and Regulatory Affairs.

🏝️ Benefits

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

• Modern office environment equipped with sit/stand desks.

• Health and wellness facilities available.

• Fully stocked kitchen.

• Access to outdoor amenities.

• On-site daycare services.

• Enclosed parking facilities.

• Complimentary on-site gym.

• Conveniently located near a SkyTrain station.

• Committed to being an equal opportunity employer.

• Interview accommodations are available upon request.