- This is a two-year fixed-term contract

- 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

- 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

Benefits

- Competitive Benefits and Vacation





- Competitive Salary

- Commute/Home Office Allowance
- Flexible Hours & WFM

- Professional Development
- Volunteer Days- Solid 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

- Understanding of quality management systems and the software development lifecycle

- Exceptional attention to detail and ability to work within strict documentation standards

- 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

- Interest in ML concepts and processes related to the design & development of AI/ML-enabled medical devices

- Knowledge of clinical study requirements and associated regulatory processes (i.e., IDEs, ITAs, IRB)

- 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

- Strategic, collaborative, analytical, focused, and self-motivated

📌 Regulatory Specialist (AI/Machine Learning Projects) (Toronto)
🏢 Clarius Mobile Health
📍 Toronto