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 good of patient care. The company is currently focused on improving the standard of care for easy orthopaedic trauma procedures commonly performed in hospital Emergency Rooms (ERs). In addition, the company has made one of its patented platforms, (DrillCover Technology™, which adapts DEWALT® drills for surgery) available at accessible price points around the globe.

The company’s products have regulatory clearances from the U.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.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. As our first dedicated QA/RA hire, you will initially be the sole owner and executor of the function.

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. Competitive salary (budgeted base salary of $115,000-125,000, depending on experience) Flexible working hours and hybrid arrangements A purpose-driven workplace with passionate teammates who want to help patients and make a positive difference in the world Lead the QA/RA Function & Team Provide 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) Apply a pragmatic approach: ensuring compliance without unnecessary complexity Document control Training systems and records Equipment and process controls CAPA and complaint handling Conduct CAPA trend analysis and report insights to leadership Ensure all quality records are accurate, complete, and audit‑ready Facility Transition Ensure QMS compliance throughout the facility relocation to Burnaby Update documentation, risk assessments, and processes tied to the new site Support validation and readiness of the new facility Audit & Compliance Leadership Act as the primary QA contact during internal and external audits Set and track annual quality objectives with senior leadership Present KPIs, trends, and quality insights across the organization Product & Design Quality Partner with Engineering to balance speed, compliance, and practicality Lead Quality Reviews with Operations and Engineering to drive continuous improvement Partner with Supply Chain on supplier qualification, monitoring, and performance Ensure quality consistency across sterile kits and components Lead CAPAs and complaint investigations: Root cause analysis Support new supplier approvals (including regulatory requirements) Regulatory Affairs Own 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. 5–10+ years in Quality Assurance and Regulatory Assurance leadership within medical devices or an equivalent controlled manufacturing environment ~(Background in a technical field (engineering, science, or equivalent) ~ Strong communication skills (including customer‑facing quality discussions) ~ Experience with MDSAP and/or FDA regulatory requirements Experience supporting U.S. regulatory operations (e.g., Experience supporting or leading facility changes, audits, or scaling environments Experience with internationally recognized standards for medical device development (e.g., You are comfortable setting direction for the function while rolling up your sleeves to solve problems and get critical work across the finish line.

You protect quality without slowing the business Arbutus Medical is reinventing how surgery is done Outside the OR™, 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 SwiftKit™ (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 Inclusion Arbutus 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. 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. 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.

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