About Myant Health At Myant Health, we are defining the Internet of Humans, a new generation of healthcare technology that connects people, AI, and machines through the power of textile computing. Our vision is to transform everyday textiles into intelligent, connected interfaces that can sense, understand, and ultimately respond to the human body.

At Myant Health, we are defining the Internet of Humans, a new generation of healthcare technology that connects people, AI, and machines through the power of textile computing. Our vision is to transform everyday textiles into intelligent, connected interfaces that can sense, understand, and ultimately respond to the human body.

At the centre of this vision is HumanOS, our platform for creating a personal health digital twin and bringing together information from textile-based sensors, medical devices, wearables, and other connected technologies. By combining multimodal sensing, biometrics, AI, and clinical intelligence, we are building a more connected and continuous approach to understanding health.

Our SKIIN™ technology turns everyday clothing into a sophisticated health interface, designed to feel like normal clothing while capturing meaningful, clinical-grade health information. Our technology is being applied across major areas of health, including cardiovascular disease, sleep, hypertension, diabetes, musculoskeletal health, and other chronic conditions.

Our immediate focus is delivering a new standard of care through objective measurement, beginning with accessible diagnostic solutions such as 14-day cardiac monitoring, home sleep apnea testing, and ambulatory blood pressure monitoring. Through our broader ecosystem, including technologies such as FIGUR8,



we are extending objective health measurement into additional areas of care.

But our ambition goes beyond diagnostics. We are building toward a future where everyday textiles can become continuous diagnostic and therapeutic interfaces, helping individuals, families, and healthcare professionals understand health earlier, manage it more proactively, and intervene when it matters most.

At Myant Health, you will have the opportunity to work at the intersection of textile computing, AI, software, hardware, biometrics, clinical science, and healthcare to help build technology that could fundamentally change how people experience and manage their health.

This is not simply a wearable technology company. We are building the infrastructure for a more connected human health ecosystem.

Role Overview:

Myant is looking for an experienced Regulatory Affairs Manager to support the commercialization and continued development of our medical device and digital health portfolio. This is a hands-on regulatory role supporting the transition of Myant's SKIIN™ wearable medical devices and Software as a Medical Device (SaMD) products from development through regulatory submission, commercialization and post-market activities.

The Regulatory Affairs Manager will develop and execute regulatory strategies across Canada, the United States and Europe, working closely with Product, Engineering, Clinical, Quality,



Manufacturing and other cross-functional teams. The successful candidate will have demonstrated experience bringing medical devices to market, with particular strength in software/digital health, wearable medical devices, New Product Introduction (NPI), regulatory submissions and regulatory requirements within an ISO 13485/MDSAP Quality Management System.

This role is suited to a regulatory professional who is comfortable working in a rapid-moving, multidisciplinary environment and who can translate regulatory requirements into practical actions that enable product development and commercialization.

Key Responsibilities

- Develop and execute regulatory strategies for new medical devices, software products and modifications to existing products
- Lead or support regulatory submissions and approvals across Health Canada, FDA and European regulatory frameworks, including applicable medical device and SaMD submissions
- Prepare and maintain regulatory submission documentation, including technical documentation, regulatory dossiers, submission correspondence and supporting evidence
- Support Health Canada Medical Device Licence (MDL) applications and amendments, as applicable
- Support preparation of FDA 510(k), De Novo and/or other applicable submissions, including interaction with regulatory authorities where required
- Support European regulatory activities under the EU MDR, including CE-marking activities, technical documentation and conformity assessment
- Develop regulatory strategies for software and SaMD, including regulatory classification, intended use, software lifecycle considerations, changes and updates
- Provide regulatory input throughout New Product Introduct

📌 Regulatory Affairs Manager (Mississauga)
🏢 Myant
📍 Mississauga