Regulatory Specialist – AI/ML Projects

Clarius Mobile Health; Canada; On-site; CAD 85,000 - 105,000; Full time

Job summary

Clarius Mobile Health is seeking an experienced Regulatory Specialist to support Regulatory Affairs and Data Science in shaping regulatory strategies for AI/ML-enabled medical devices. The role is a two-year fixed-term contract open to candidates across Canada.

You will translate ML concepts into regulatory documentation, prepare submissions (FDA 510(k), Health Canada, EU MDR), maintain DHF and documentation, and ensure compliance with ISO and MDSAP standards.

Qualifications

• 5+ years of experience in a regulated industry (e.g., Medtech) with AI/ML-enabled products
• Deep understanding of ISO 13485, IEC 62304, ISO 14971, IEC 62366, MDSAP, EU MDR, FDA and Health Canada medical device regulatory requirements for AI/ML-enabled devices and SaMD
• Ability to translate ML concepts into regulatory documentation and DHF creation
• Experience with FDA 510(k) submissions and Health Canada / EU MDR filings
• Strong written and verbal communication with cross-functional teams including R&D, Data Science, and Regulatory Affairs

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 (Health Canada, EU MDR)
• Collaborate with RA team on regulatory technical documentation and DHF documentation requirements
• Maintain version control and document change management

Skills

Regulatory compliance

Regulatory submissions

Documentation

Cross-functional collaboration

Attention to detail

Time management

Communication skills

Education

Post-secondary education in a scientific/technical field

Job description

A Career at ClariusToday, as many as 25 million medical professionals globally don’t have access to medical imaging, which is proven to improve patient care and reduce healthcare costs. That’s why we’re on a mission to make medical imaging accessible everywhere by delivering high-performance, affordable, and easy-to-use solutions powered by artificial intelligence and connected to the cloud.By making Clarius your next career move, you’re joining a team of 140+ people who are talented, innovative, and highly collaborative. You’re also joining a community that includes thousands of physicians worldwide who use Clarius to deliver better patient care! And you’re joining a thrice-certified Great Place to Work!

Your Role

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.

Your Responsibilities Include:

• 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

Your Experience So Far:

• 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)

Location and Compensation:

This is a two-year fixed-term contract open to candidates across Canada. The salary range for this role is set at $85,000-$105,000

More Reasons to Consider:

• Be Part of a High-Impact Project – You’ll play a key role in creating a more affordable ultrasound solution, making medical imaging more accessible worldwide.
• Work for a Three-Time Certified Great Place to Work – Clarius has been recognized three times as a great place to work, and you’ll be joining a company that values innovation, teamwork, and employee well-being.
• Workspace: Our modern office features sit/stand desks, various health & wellness facilities, a stocked kitchen, outdoor amenities, on-site daycare, enclosed parking, a free on-site gym and close proximity to a SkyTrain station.

Clarius Mobile Health is proud to be an Equal Opportunity Employer. We encourage applications from any qualified candidate regardless of ethnicity, religion, age, national origin, disability status, sexual orientation, gender identity or expression. Please let us know if you require any accommodations during the interview process.

Use of Artificial Intelligence in the Recruitment Process

As part of our recruitment and assessment process, we may use artificial intelligence tools to support certain activities. This may include, but is not limited to, reviewing applications, supporting candidate assessments, and conducting or facilitating one way video interviews. Where AI tools are used, they are intended to support our recruitment process and do not replace human decision making. Candidates may be informed where AI is used as part of an assessment and will have the opportunity to engage with the recruitment process in accordance with applicable laws and our recruitment practices.