Quality and Regulatory ManagerSmarter Alloys | Cambridge, ON (On Site) Full time, permanentThe RoleThis is a role where quality and regulatory work directly enables products to reach market. You will own our ISO 13485 system, lead audits, and guide regulatory strategy for current and existing medical device products, but the real impact is in clearing the path from development to commercialization.We need someone who can balance maintaining a certified QMS with actively supporting new product introductions, navigating regulatory submissions, and working shoulder to shoulder with engineering and production as we scale.If you want a role where compliance isn't a back office function but a core part of how products get to market, this is it.About Smarter AlloysSmarter Alloys develops and manufactures advanced shape memory alloy materials and devices for medical, dental, automotive, consumer, and energy applications. We are certified to ISO 13485 MDSAP and registered with the FDA and Health Canada. Our product portfolio is expanding, our customer base is growing, and we need a quality and regulatory leader who can scale with us.What You Will DoLead internal and external audits, including ISO surveillance audits, customer audits, and regulatory inspectionsOwn and maintain the ISO 13485 Quality Management System, ensuring ongoing compliance and continuous improvementSupport regulatory activities for medical device products, including FDA establishment registration and listingGuide regulatory requirements for new product development from concept through commercializationOversee CAPA, nonconformance management, and continuous improvement initiativesMaintain and improve quality documentation including SOPs, work instructions, risk management files,



and technical filesSupport supplier qualification, monitoring, and quality agreementsTrain and support internal teams on quality system requirements and regulatory expectationsCollaborate cross functionally with engineering, production, procurement, and business developmentServe as the primary point of contact for quality and regulatory matters, internally and externallyWho You AreBachelor's degree in Engineering, Science, or a related technical discipline4+ years of experience in quality and regulatory roles within the medical device industryStrong working knowledge of ISO 13485 and FDA Quality System RegulationDemonstrated experience leading audits and managing regulatory inspectionsProven ability to manage and improve a QMS in a hands on environmentStrong documentation, organizational, and communication skillsAble to work independently and exercise sound judgment in a regulated settingStrongest candidates will also have:Experience supporting dental or Class I/II medical devicesFamiliarity with ISO 14971 (risk management)Experience in a startup or growing organizationExposure to advanced materials or precision manufacturing environmentsExperience supporting regulatory submissions or international registrationsWhat We OfferCompetitive compensation package with full benefits and paid vacationThe chance to own and shape the quality function at a company with real momentumDirect impact on products reaching market. Your work clears the path.A fast moving, collaborative team that values results and initiativeOn site role based out of our Cambridge, ON facilitySmarter Alloys is committed to building a diverse and inclusive team. We welcome applications from women, visible minorities, Indigenous peoples, people identifying as LGBTQ2SI+, veterans, and people with disabilities. #J-18808-Ljbffr

📌 Quality And Regulatory Manager (Cambridge)
🏢 Smarter Alloys
📍 Cambridge