Regulatory Affairs Lead – MedTech & SaMD Wearables

Myant Inc.; Mississauga; On-site; CAD 90,000 - 130,000; Full time

Job summary

Myant Health is seeking a Regulatory Affairs Manager to support the commercialization of our SKIIN wearable medical devices and SaMD. You will lead regulatory strategy across Canada, the United States and Europe, working with cross-functional teams to translate requirements into actionable development plans.

You will manage regulatory submissions, maintain eQMS documentation, and ensure ongoing compliance with ISO 13485/MDSAP and applicable medical device regulations.

Qualifications

• Bachelor's degree or equivalent in a related field
• Several years of Regulatory Affairs experience in medical devices
• Experience with Canada/US/Europe regulatory requirements
• Experience with SaMD and ISO 13485/MDSAP is preferred
• Experience with regulatory submissions and audits

Responsibilities

• Develop regulatory strategies for new medical devices and software.
• Lead or support submissions to Health Canada, FDA and European authorities.
• Prepare technical documentation and regulatory dossiers.
• Support MDL/MDEL, FDA 510(k) and MDR CE marking activities.
• Collaborate with product, engineering, QA and clinical teams.
• Maintain regulatory documentation within the eQMS and ensure audit readiness.
• Monitor regulatory changes and assess impact on products.
• Participate as internal auditor within QMS.

Skills

Regulatory affairs

SaMD

Regulatory submissions

cross-functional collaboration

Education

Bachelor's degree in Biomedical Engineering or related

Tools

eQMS

Regulatory databases

Job description

Myant Health is seeking a Regulatory Affairs Manager to support the commercialization of our SKIIN wearable medical devices and SaMD. You will lead regulatory strategy across Canada, the United States and Europe, working with cross-functional teams to translate requirements into actionable development plans.

You will manage regulatory submissions, maintain eQMS documentation, and ensure ongoing compliance with ISO 13485/MDSAP and applicable medical device regulations.