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Added 8 mins ago
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Clarius Mobile Health

Senior Regulatory Specialist, AI/ML Projects

Toronto, ON, Canada

The salary range for this role is set at $85,000-$105,000 · Temporary

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Job details

Pay: The salary range for this role is set at $85,000-$105,000
Job type: Temporary
Experience: 5+ years of experience in a regulated industry (e.g., Medtech) with direct experience working on AI/ML-enabled products and regulatory submissions
Posting language: English
Posted: Oct 28, 2026

Original job description

A Career at Clarius

Today, 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.

Requirements

Post-secondary education in a scientific or technical field or equivalent experience
5+ years in a regulated medical device environment, with hands-on ownership of pre-market submissions (FDA 510(k) or equivalent) for AI/ML-enabled devices

Hands-on experience designing or running prospective clinical studies for AI/ML devices, including IDE, ITA and IRB pathways
Working knowledge of FDA guidance for AI/ML and SaMD, including CAD vs CDS classification
Able to lead regulatory strategy independently, with minimal guidance
Working 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, preferred.
Working knowledge of ML concepts (training, performance metrics, bias), preferred.
Experience working with data science and engineering teams, preferred.
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

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More about this job

Responsibilities

Develop and execute regulatory strategies for AI/ML-enabled medical devices in collaboration with machine learning engineers and Regulatory Affairs. Prepare and maintain detailed technical, design history, data, verification, validation, and submission documentation, including materials for FDA 510(k) and equivalent international submissions.

Requirements

Requires post-secondary education in a scientific or technical field, or equivalent experience, and at least five years in a regulated medical device environment with hands-on ownership of AI/ML device pre-market submissions. Candidates should understand relevant medical device regulations and standards, AI/ML and SaMD guidance, clinical study pathways, quality systems, and software development, and be able to lead regulatory strategy independently.

Skills

Regulatory Strategy
AI/ML Medical Devices
Regulatory Submissions
FDA 510(k)
SaMD
Clinical Study Requirements
ISO 13485
IEC 62304
ISO 14971
IEC 62366
MDSAP
EU MDR
Health Canada Regulations
Document Change Management

Benefits

Sit-Stand Desks
Health and Wellness Facilities
Stocked Kitchen
Outdoor Amenities
On-Site Daycare
Enclosed Parking
Free On-Site Gym

Visa sponsorship

Not detected in the job text

Keywords

Artificial Intelligence
Machine Learning
AI/ML-Enabled Medical Devices
Software as a Medical Device
Regulatory Affairs
FDA 510(k)
Health Canada
EU MDR
ISO 13485
IEC 62304
ISO 14971
IEC 62366
MDSAP
Design History File
Quality Management System
Clinical Studies
IDE
ITA
IRB
Computer-Aided Detection
Clinical Decision Support
Model Training
Data Preparation
Performance Metrics
Bias Assessment
Verification and Validation
Document Change Management
Medical Imaging
Ultrasound

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