Regulatory Specialist – AI/ML Projects

Clarius Mobile Health•Toronto, ON

17h•CA$85,000 - CA$105,000•Onsite

About The Position

We're seeking an experienced Regulatory Specialist to support our Data Science and Regulatory Affairs teams in defining and executing regulatory strategies for AI/ML-enabled medical devices. You'll need deep expertise in the regulatory landscape for AI/ML devices, including AI/ML design and development methodologies, SaMD requirements, and the software development lifecycle. Over the next 24 months, your primary responsibilities will be translating complex machine learning concepts into clear, precise regulatory documentation including DHF creation, regulatory submission preparation, and related data documentation. This is a two-year fixed-term contract.

Requirements

Post-secondary education in a scientific or technical field or equivalent experience
5+ years of experience in a regulated industry (e.g., Medtech) with direct experience working on AI/ML-enabled products and regulatory submissions
Interest in ML concepts and processes related to the design & 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 medical device regulatory requirements for AI/ML-enabled medical devices and SaMD
Understanding of quality management systems and the software development lifecycle
Strategic, collaborative, analytical, focused, and self-motivated
Exceptional attention to detail and ability to work within strict documentation standards
Strong time-management skills and ability to prioritize tasks in a fast-paced environment
Strong communication skills (verbal and written) and ability to work effectively with cross-functional teams including R&D, Data Science, and Regulatory Affairs
Knowledge of clinical study requirements and associated regulatory processes (i.e., IDEs, ITAs, IRB)

Responsibilities

Collaborate with ML engineers and RA team to define and execute regulatory strategies for AI/ML products
Maintain clear, detailed documentation of ML algorithms, datasets, and performance metrics for regulatory review
Create technical documentation, including AI/ML model training methodologies, data preparation procedures, and model verification and validation documentation
Collaborate with RA team to write technical sections of FDA 510(k) and equivalent submissions (e.g., Health Canada, EU MDR).
Collaborate with RA team on regulatory technical documentation and DHF documentation requirements
Maintain version control and document change management