Arbutus Medical Inc. is a privately held ISO13485 medical device company headquartered in Vancouver, Canada. Arbutus Medical is a medical device innovation engine that streamlines surgical inefficiencies for the valuable of patient care.The company is currently focused on improving the standard of care for straightforward orthopaedic trauma procedures commonly performed in hospital Emergency Rooms (ERs). Its two leading products are TrakPak®, a procedure kit that streamlines bedside skeletal traction, and Digit Revision SwiftKitTM, a procedure kit that streamlines revision amputations of fingers and toes.In addition, the company has made one of its patented platforms, (DrillCover TechnologyTM, which adapts DEWALT® drills for surgery) available at accessible price points around the globe. The company's products have regulatory clearances from the U.S. Food & Drug Administration (FDA) and Health Canada, and have been used by customers in 40 countries, enabling an estimated 130,000 surgeries to date. For more information about Arbutus Medical, visit arbutusmedical.Com and follow the company on LinkedIn.We are seeking a hands-on Manager, Quality Assurance & Regulatory Affairs (QA/RA) to lead our Quality and Regulatory function and own the systems that ensure our products and operations meet applicable quality and regulatory requirements.This is an opportunity for someone who is ready to take meaningful ownership of the function. As our first dedicated QA/RA hire, you will initially be the sole owner and executor of the function. You will be expected to roll up your sleeves and directly execute the work. From CAPAs, complaints and investigations to audit preparation, QMS management, regulatory activities, and cross-functional problem solving.As Arbutus continues to grow, you will also be responsible for building the QA/RA function around you: identifying resource and capability needs, hiring your team, and developing the systems and structure required to support the organization at scale. This role therefore requires someone who is equally comfortable doing the work today and building and leading the team for tomorrow.You will be joining Arbutus at an important stage of growth. We are looking for someone who can build scalable systems without introducing unnecessary complexity: protecting product quality, patient safety, and compliance while helping the organization move quickly and effectively.What We OfferCompetitive salary (budgeted base salary of $115,000-125,000, depending on experience)An exciting opportunity to get in at the ground floor of a growing ventureFlexible working hours and hybrid arrangementsExtended health benefitsA purpose-driven workplace with passionate teammates who want to help patients and make a positive difference in the worldKey Responsibilities:Lead the QA/RA Function & TeamProvide day-to-day leadership and direction to the Quality and Regulatory Affairs activities.Set priorities, clarify accountabilities, and ensure critical QA/RA activities are completed effectively and on time.Coach and develop team members, building capability and increasing ownership across the function.Establish clear goals, KPIs,



and expectations for the QA/RA function.Act as a hands‐on leader who can move between managing the function and directly executing critical work when required.Build strong cross-functional relationships with Engineering, Operations, Supply Chain, Product, Commercial, and senior leadership.Help evolve the QA/RA function as the organization grows, identifying future resource, capability, and system needs.Own & Scale the Quality Management System (QMS)Maintain and continuously improve an ISO 13485 / MDSAP‐compliant QMSApply a pragmatic approach: ensuring compliance without unnecessary complexityEnsure audit readiness across:Document controlTraining systems and recordsEquipment and process controlsCAPA and complaint handlingIdentify system gaps and implement scalable, practical solutionsConduct CAPA trend analysis and report insights to leadershipEnsure all quality records are accurate, complete, and audit‐readyFacility TransitionEnsure QMS compliance throughout the facility relocation to BurnabyUpdate documentation, risk assessments, and processes tied to the new sitePartner cross‐functionally with Operations to minimize disruptionSupport validation and readiness of the new facilityAudit & Compliance LeadershipLead preparation for the ISO 13485 surveillance auditAct as the primary QA contact during internal and external auditsSet and track annual quality objectives with senior leadershipPresent KPIs, trends, and quality insights across the organizationProduct & Design QualityDevelop and implement test strategies and validation plansPartner with Engineering to balance speed, compliance, and practicalityLead Quality Reviews with Operations and Engineering to drive continuous improvementPartner with Supply Chain on supplier qualification, monitoring, and performanceEnsure quality consistency across sterile kits and componentsLead CAPAs and complaint investigations:Root cause analysisCorrective actionsTimely closureSupport new supplier approvals (including regulatory requirements)Regulatory AffairsOwn and coordinate regulatory activities required to maintain market access for Arbutus Medical products.Maintain applicable product registrations, establishment registrations, listings, and regulatory documentation.Support and maintain FDA UDI/GUDID requirements and regulatory database submissions, ensuring information remains accurate and current.Monitor changes to applicable regulatory requirements and assess their impact on products, processes, and the QMS.Support regulatory submissions, registrations, renewals, and change assessments as required.Ensure regulatory requirements are appropriately incorporated into product development, manufacturing, supplier,



and quality processes.Partner with Engineering and Product teams to assess the regulatory implications of product and design changes.Maintain organized and audit‐ready regulatory records and documentation.Serve as an internal resource on regulatory requirements, helping teams understand both what is required and the most efficient compliant path forward.Requirements5–10+ years in Quality Assurance and Regulatory Assurance leadership within medical devices or an equivalent controlled manufacturing environment(ISO 13485 setting or equivalent)Experience owning the functionsStrong working knowledge of:ISO 13485 or equivalentProven experience with:Audits (internal & external)CAPA systemsQMS ownershipBackground in a technical field (engineering, science, or equivalent)Strong communication skills (including customer‐facing quality discussions)Ability to operate in a fast‐paced, scaling environmentNice-to-HaveExperience with MDSAP and/or FDA regulatory requirementsBackground with Class I/II devices, sterile products, or orthopaedicsISO 13485 or ISO 9001 Lead Auditor certificationExperience supporting U.S. regulatory operations (e.G., UDI submissions)Experience supporting or leading facility changes, audits, or scaling environmentsExperience with internationally recognized standards for medical device development (e.G., ISO10993, ISO14971, IEC 60601, ISO 11135, ISO 11137)Desired Capabilities and TraitsHands‐on leader: You are comfortable setting direction for the function while rolling up your sleeves to solve problems and get critical work across the finish line.Pragmatic problem solver: You know what's required vs. what's unnecessaryDetail‐oriented: You ensure systems hold up under audit scrutinyCross‐functional partner: You build trust across Engineering, Ops, and Supply ChainBalanced mindset: You protect quality without slowing the businessWhy this role, andwhy now?Arbutus Medical is reinventing how surgery is done Outside the ORTM, starting within the ER, where surgeons struggle with 1M+ bedside procedures a year due to outdated workflows. We're building the market's first portfolio of procedure kit "grab bags" to streamline these procedures, and have launched two FDA‐cleared products to date, TrakPak® (to streamline bedside skeletal traction) and SwiftKitTM (to streamline treatment of fingertip trauma). These are two truly differentiated products that solve practical workflow problems, saving up to 45 min/patient, helping hospitals win back resources and keep staff happy, while improving quality of patient care.Our Commitment to Diversity, Equity, and InclusionArbutus Medical is committed to making diversity, equity, and inclusion part of everything we do, from how we build our products to how we build our workforce.Also, let us know if we can provide any specific accessibility considerations throughout the interview and candidate screening process.Our salary budgets are designed using comprehensive market data and to reflect the range of skills and experience we need for the position and allow room for growth. For experienced individuals we typical hire at the mid-point of the band. The top portion is reserved for employees who demonstrate sustained high performance and impact at Arbutus. Those who are new to the role may join below the mid-point and develop their skills overtime. The final offer amount for this role will depend on applicable skill set of the candidate.

📌 Quality Assurance Regulatory Affairs Manager (Burnaby)
🏢 Arbutus Medical
📍 Burnaby