Bachelor's degree in Biomedical Engineering, Engineering, Software, Life Sciences, or related field.
Several years of progressive Regulatory Affairs experience in the medical device industry.
Demonstrated experience with regulatory requirements in Canada, the U.S., and/or Europe.
Hands-on experience with medical device regulatory submissions.
Experience with Software as a Medical Device (SaMD) and digital health products.
Familiarity with ISO 13485 and/or MDSAP Quality Management Systems.
Strong project management and communication skills.
Responsibilities
Develop and execute regulatory strategies for new and existing medical devices and software products.
Lead regulatory submissions and approvals across Health Canada, FDA, and European frameworks.
Prepare and maintain regulatory submission documentation and technical dossiers.
Support Health Canada MDL applications and FDA 510(k) submissions.
Monitor changes to regulations and assess their impact on products.
Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
Manage regulatory projects and communicate risks to stakeholders.
Benefits
Collaborative and multidisciplinary work environment.
Opportunity to influence product development and commercialization.
Engagement in innovative medical device and digital health projects.
Support for continuous improvement of regulatory processes.
Potential for professional development and growth within the company.
Full Job Description
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 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 Introduction (NPI) and product development, ensuring regulatory requirements are incorporated early in the design and development process.
Assess regulatory impact of product changes, software releases, design changes, manufacturing changes and other modifications through established change-control processes.
Monitor changes to applicable regulations, standards and regulatory guidance and assess their impact on Myant products and processes.
Work closely with Quality Assurance to ensure regulatory activities are appropriately integrated within the ISO 13485/MDSAP Quality Management System.
Collaborate with Product, Engineering, Software, Clinical, Quality, Manufacturing and Commercial teams to ensure products meet applicable regulatory, quality and safety requirements.
Support regulatory aspects of clinical and performance activities, including determining applicable regulatory requirements and documentation.
Maintain regulatory documentation, records and submissions within Myant's electronic QMS (eQMS) to ensure traceability, accessibility and inspection readiness.
Support regulatory responses to Health Canada, FDA, Notified Bodies and other regulatory authorities.
Support post-market regulatory activities, including regulatory reporting, product changes, vigilance and other applicable regulatory requirements.
Participate in internal and external audits and support regulatory and quality inspection readiness.
Participate as an Internal Auditor within the Quality Management System.
Manage assigned regulatory projects, timelines and deliverables and communicate regulatory risks and requirements to stakeholders.
Contribute to continuous improvement of Myant's regulatory processes, procedures and systems.
Qualifications:
Bachelor's degree in Biomedical Engineering, Engineering, Software, Life Sciences, Applied Sciences or a related discipline, or equivalent relevant experience.
Several years of progressive Regulatory Affairs experience within the medical device industry.
Demonstrated experience with medical device regulatory requirements in Canada, the United States and/or Europe, with strong knowledge of at least two of these jurisdictions.
Hands-on experience preparing or supporting medical device regulatory submissions.
Demonstrated experience with Software as a Medical Device (SaMD), digital health, connected medical devices or medical device software.
Experience supporting New Product Introduction (NPI) and regulatory activities throughout the product development lifecycle.
Experience working within an ISO 13485 and/or MDSAP Quality Management System.
Experience with regulatory requirements for wearable, connected and/or patient-worn medical devices is highly desirable.
Strong understanding of regulatory requirements, standards and guidance applicable to medical devices and software.
Experience working with an electronic Quality Management System (eQMS) and controlled regulatory documentation.
Experience supporting internal or external ISO 13485, MDSAP, EU MDR or regulatory authority audits.
Strong project management, organizational, documentation and communication skills.
Ability to work effectively with technical and non-technical stakeholders across a multidisciplinary organization.
Ability to manage multiple regulatory projects and priorities in a fast-paced commercialization environment.
Preferred:
Experience with FDA 510(k), De Novo or other FDA medical device pathways.
Experience with Health Canada MDL/MDEL requirements.
Experience with EU MDR technical documentation and CE marking.
Experience with regulatory requirements related to clinical evaluation, software lifecycle, cybersecurity, risk management and usability/human factors.
Experience with IEC 62304, ISO 14971, IEC 62366 and/or other medical device software and risk-management standards.
Experience with regulatory strategy for connected/IoT medical devices.
Internal Auditor, RAC, RAPS, ISO 13485 Auditor or equivalent certification.
Experience working with regulators, Notified Bodies, Certification Bodies or external regulatory consultants.
What We're Looking For
A hands-on regulatory professional who can independently drive regulatory deliverables rather than only provide regulatory advice.
Someone who understands how to translate regulatory requirements into practical product-development activities.
Strong attention to detail without losing sight of commercialization timelines.
Comfortable working with engineers, software developers, product managers, clinicians, quality professionals and senior leadership.
Strong ownership, follow-through and ability to identify regulatory risks early.
A collaborative team player who is comfortable operating in an evolving, technology-driven medical device environment.
