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 outlining and implementing regulatory strategies for AI/ML-enabled medical devices.

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

• Develop Design History File (DHF) documentation.

• Prepare regulatory submissions and associated data documentation.

• Collaborate with ML engineers and Regulatory Affairs to define and carry out AI/ML product regulatory strategies.

• Document ML algorithms, datasets, and performance metrics for regulatory assessment.

• Generate technical documentation detailing model training methodologies, data preparation, and verification and validation of models.

• Compose technical sections of FDA 510(k), Health Canada, and EU MDR submissions in cooperation with the Regulatory Affairs team.

• Provide support for regulatory technical documentation and DHF documentation requirements.

• Oversee version control and document change management.

⛳️ Requirements

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

• 5+ years of experience in a regulated sector, such as Medtech, with direct involvement in AI/ML-enabled products and regulatory submissions.

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

• Proficient knowledge of ISO 13485, IEC 62304, ISO 14971, IEC 62366, MDSAP, EU MDR, FDA, and Health Canada medical-device regulatory requirements for AI/ML-enabled medical devices and Software as a Medical Device (SaMD).

• Familiarity with quality management systems and the software development lifecycle.

• A strategic, collaborative, analytical, focused, and self-driven mindset.

• Exceptional attention to detail with the ability to adhere to strict documentation standards.

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

• Excellent verbal and written communication skills.

• Capacity to work efficiently with cross-functional R&D, Data Science, and Regulatory Affairs teams.

• Knowledge of clinical study requirements and regulatory processes, including Investigational Device Exemptions (IDEs), Investigational Testing Applications (ITAs), and Institutional Review Boards (IRBs).

🏝️ Benefits

• Engage in high-impact projects that contribute to more affordable ultrasound and enhanced accessibility to medical imaging.

• Work in a three-time Certified Great Place to Work environment.

• Enjoy a modern office equipped with sit/stand desks.

• Access health and wellness facilities.

• Utilize a fully stocked kitchen.

• Benefit from outdoor amenities.

• Take advantage of on-site daycare services.

• Secure enclosed parking.

• Access a free on-site gym.

• Enjoy close proximity to a SkyTrain station.

• Be part of an Equal Opportunity Employer.

• Request interview accommodations as needed.