Regulatory Affairs Manager

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 fast-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 productsLead or support regulatory submissions and approvals across Health Canada, FDA and European regulatory frameworks, including applicable medical device and SaMD submissionsPrepare and maintain regulatory submission documentation, including technical documentation, regulatory dossiers, submission correspondence and supporting evidenceSupport Health Canada Medical Device Licence (MDL) applications and amendments, as applicableSupport preparation of FDA 510(k), De Novo and/or other applicable submissions, including interaction with regulatory authorities where requiredSupport European regulatory activities under the EU MDR, including CE-marking activities, technical documentation and conformity assessmentDevelop regulatory strategies for software and SaMD, including regulatory classification, intended use, software lifecycle considerations, changes and updatesProvide regulatory input throughout New Product Introduction (NPI) and product development, ensuring regulatory requirements are incorporated early in the design and development processAssess regulatory impact of product changes, software releases, design changes, manufacturing changes and other modifications through established change-control processesMonitor changes to applicable regulations, standards and regulatory guidance and assess their impact on Myant products and processesWork closely with Quality Assurance to ensure regulatory activities are appropriately integrated within the ISO 13485/MDSAP Quality Management SystemCollaborate with Product, Engineering, Software, Clinical, Quality, Manufacturing and Commercial teams to ensure products meet applicable regulatory, quality and safety requirementsSupport regulatory aspects of clinical and performance activities, including determining applicable regulatory requirements and documentationMaintain regulatory documentation, records and submissions within Myant's electronic QMS (eQMS) to ensure traceability, accessibility, and inspection readinessSupport regulatory responses to Health Canada, FDA, Notified Bodies and other regulatory authoritiesSupport post-market regulatory activities, including regulatory reporting, product changes, vigilance and other applicable regulatory requirementsParticipate in internal and external audits and support regulatory and quality inspection readinessParticipate as an Internal Auditor within the Quality Management SystemManage assigned regulatory projects, timelines and deliverables and communicate regulatory risks and requirements to stakeholdersContribute to continuous improvement of Myant's regulatory processes, procedures and systemsQualifications
Bachelor's degree in Biomedical Engineering, Engineering, Software, Life Sciences, Applied Sciences or a related discipline, or equivalent relevant experienceSeveral years of progressive Regulatory Affairs experience within the medical device industryDemonstrated experience with medical device regulatory requirements in Canada, the United States and/or Europe, with strong knowledge of at least two of these jurisdictionsHands‑on experience preparing or supporting medical device regulatory submissionsDemonstrated experience with Software as a Medical Device (SaMD), digital health, connected medical devices or medical device softwareExperience supporting New Product Introduction (NPI) and regulatory activities throughout the product development lifecycleExperience working within an ISO 13485 and/or MDSAP Quality Management SystemExperience with regulatory requirements for wearable, connected and/or patient‑worn medical devices is highly desirableStrong understanding of regulatory requirements, standards and guidance applicable to medical devices and softwareExperience working with an electronic Quality Management System (eQMS) and controlled regulatory documentationExperience supporting internal or external ISO 13485, MDSAP, EU MDR or regulatory authority auditsStrong project management, organizational, documentation and communication skillsAbility to work effectively with technical and non-technical stakeholders across a multidisciplinary organizationAbility to manage multiple regulatory projects and priorities in a fast‑paced commercialization environmentPreferred
Experience with FDA 510(k), De Novo or other FDA medical device pathwaysExperience with Health Canada MDL/MDEL requirementsExperience with EU MDR technical documentation and CE markingExperience with regulatory requirements related to clinical evaluation, software lifecycle, cybersecurity, risk management and usability/human factorsExperience with IEC 62304, ISO 14971, IEC 62366 and/or other medical device software and risk‑management standardsExperience with regulatory strategy for connected/IoT medical devicesInternal Auditor, RAC, RAPS, ISO 13485 Auditor or equivalent certificationExperience working with regulators, Notified Bodies, Certification Bodies or external regulatory consultantsWhat We're Looking For
A hands‑on regulatory professional who can independently drive regulatory deliverables rather than only provide regulatory adviceSomeone who understands how to translate regulatory requirements into practical product‑development activitiesStrong attention to detail without losing sight of commercialization timelinesComfortable working with engineers, software developers, product managers, clinicians, quality professionals and senior leadershipStrong ownership, follow‑through and ability to identify regulatory risks earlyA collaborative team player who is comfortable operating in an evolving, technology‑driven medical device environment
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