Regulatory Specialist, Clarius Mobile Health
AI/Machine Learning Projects
CA$85-105k
Portable handheld ultrasound systems
Posted today
Portable handheld ultrasound systems
101-200 employees
Posted today
CA$85-105k
101-200 employees
Company mission
To make ultrasound more accessible with an affordable, intuitive solution.
Role
Who you are
- 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)
What the job involves
- 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
Our take
The big issue with handheld ultrasound isn't the device - it's reading the images. These tools are now portable and affordable enough for everyday use, but interpreting blurry, grayscale scans (especially of complex organs like the heart) still requires specialist training. So that leaves many primary care doctors relying on referrals, which can slow down diagnosis for common but serious issues.
Clarius Mobile Health builds handheld ultrasound devices paired with AI software to tackle this issue and interpret scans in real time. Its T-Mode feature splits the screen to show both the standard image and a color-coded, labeled version, making anatomy much easier to understand. Clarius has expanded this across multiple use cases and developed 16 AI models (6 FDA-cleared), with its devices used for nearly 7M scans worldwide.
This is obviously a huge deal, the company unsurprisingly reached profitability in 2025 and reported around 20% growth, while expanding to more than 70 countries. Its focus on making ultrasound easier to use (not just more portable) puts it in a very good position for the future. If this kind of adoption continues, it could help turn ultrasound into a routine tool in everyday primary care.
Freddie
Company Specialist at Welcome to the Jungle
Insights
17% employee growth in 12 months
Company
Funding (last 2 of 4 rounds)
Dec 2015
$16.5m
SERIES B
Jun 2014
$6.5m
SERIES A
Total funding: $24.1m
Company benefits
- Competitive Benefits and Vacation
- Competitive Salary
- Commute/Home Office Allowance
- Flexible Hours & WFM
- Professional Development
- Volunteer Days
Company HQ
Renfrew-Collingwood, Vancouver, BC
Leadership
Laurent Pelissier
(Founder & CEO)Prior to founding Clarius in 2015, Laurent was the founder of Ultrasonix, where he served as the CEO for 13 years. Her also served as a Director at the Medical Device Development Centre for 15 years.
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