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Added 3 hours ago
SE
network technical specialist
Sherwood Electromotion Inc.
Concord, ON
- Full-time
Perform routine network start up and close down and maintain control records
Added 4 hours ago
W
Corporate Procurement Specialist
Worley
AB
- Full-time
Worley Canada Construction is seeking an experienced Procurement Specialist to support project-site procurement. This hands-on role is responsible for timely, accurate, and commercially…
Added 4 hours ago
HT
Advanced Applications Blow Molding Specialist
Husky Technologies
Bolton, ON
- Full-time
Title: Advanced Applications Blow Molding Specialist
Added 5 hours ago
A
Subcontracts Specialist
Actalent
North Vancouver, BC
- $44 to $53 CAD / hour
- Contract
Job Title: Subcontracts Specialist IIIJob Description
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A
Pi Historian Systems Specialist
Actalent
Calgary, AB
- $40 to $60 CAD / hour
- Full-time
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Added 5 hours ago
Reliability Specialist, Cranes Maintenance
ArcelorMittal
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(Senior Coordinator / Specialist / Senior Specialist)
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Specialist, Technical Training and Support
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Toronto, ON · North York, ON
- $73,008 to $121,680 CAD / year
The Specialist, Technical Training and Support role is a senior technical position within the Global Microbiology team functioning as an expert resource in microbiology across the…
Added 8 hours ago
F
Project Manager II
Fluor
Vancouver, BC
- Full-time
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Added 9 hours ago
Advanced Process Control Specialist / Engineer
Spartan Controls Ltd.
Calgary, AB · Edmonton, AB
We are recruiting for an Advanced Process Control (APC) Specialist/Engineer for our either our Edmonton or Calgary office. In this role, you will be responsible for participating in the…
Added 11 hours ago
R
Cybersecurity Governance & Policy Specialist
Raise
Vancouver, BC
- Full-time
Raise is currently hiring a Cybersecurity Governance & Policy Specialist on behalf of our client. They’re expanding their team to meet growing needs, making this a unique opportunity to…
Added 11 hours ago
IP
Operational Excellence Analyst
InterPro Pipe + Steel
Camrose, AB
- Full-time
5 years’ industry experience, candidates with less than 5 years of experience may be considered for a specialist role
Added 11 hours ago
IP
Operational Excellence Analyst
InterPro Pipe + Steel
AB · Edmonton, AB
- Full-time
5 years’ industry experience, candidates with less than 5 years of experience may be considered for a specialist role
Added 11 hours ago
FC
Project Manager II
Fluor Corporation
Vancouver, BC
- Full-time
Requires five (5) years of experience as Project Engineer or Specialist, or a project role of significant capacity such as Project Controls Lead, Contracts Lead, etc. and three (3) years…
Added 11 hours ago
TC
IAM Governance, Policy & Compliance Specialist
TMC Canada
Montreal, QC
- Full-time
At TMC Canada, we are recruiting an IAM Governance, Policy & Compliance Specialist to contribute to strategic cybersecurity and technology governance initiatives within a leading…
Added 12 hours ago
AA
Spécialiste intégration structures et systèmes / Structures & Systems Integration Specialist
ALTITUDE AEROSPACE
Montreal, QC · Greater Montreal Metropolitan Area
- Full-time
As part of our team growth, we are looking for a Structures & Systems Integration Specialist to contribute to configuration development, installation design and the integration of technical…
Added 13 hours ago
LS
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Added 13 hours ago
Quality and Compliance Specialist - Diagnostic Services - Repost
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Winnipeg, MB
Added 13 hours ago
DI
Controls Specialist
DuroByte Inc.
Windsor, ON
- $70,000 to $100,000 CAD / year
- Full-time
We are seeking an experienced Controls Specialist – Industrial Automation to develop, program, commission, troubleshoot, and support industrial automation systems.
Added 14 hours ago
OS
Operational Excellence Analyst
Orion Steel Group
Camrose, AB · Edmonton, AB
- Full-time
5 years’ industry experience, candidates with less than 5 years of experience may be considered for a specialist role
Added 14 hours ago
A
LEAD PQAR / QUALITY ASSURANCE OFFICER
AtkinsRéalis
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- Full-time
…Records, etc.) in MyTrak or to the applicable software use by the project as document control repository…
Added 15 hours ago
TS
Senior Architectural Technologist - Restaurants
TalentSphere Staffing Solutions
Toronto, ON
- Full-time
Related titles: Senior Technologist, Project Technologist, Technical Lead, Architectural Technologist, Senior Revit Technologist, Project Lead, Technical Lead, Senior Job Captain, Intern…
Added 15 hours ago
RU
Senior On-Site Service Specialist
Ricoh USA, Inc.
Toronto, ON
- Full-time
Added 15 hours ago
CM
Senior Specialist, Custody Services
CIBC Mellon
Toronto, ON
- Full-time
The Senior Specialist, Custody Services will provide day-to-day support to Custody Services in Toronto and Pune India in the form of professional client service, account oversight and risk…
Added 16 hours ago
AL
Laboratory Quality Assurance Specialist - Calgary
AGAT Laboratories
Calgary, AB
- Full-time
AGAT Laboratories is currently hiring for a Quality Assurance Specialist. This position will work out of our Calgary Alberta location.
Added 16 hours ago
HT
Advanced Applications Blow Molding Specialist
Husky Technologies
Bolton, ON
- Full-time
Title: Advanced Applications Blow Molding Specialist

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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