Manager, Quality Assurance & Regulatory Affairs - Arbutus Medical

About this role

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 Offer

• Competitive 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 venture

• Flexible working hours and hybrid arrangements

• Extended health benefits

• Professional development funding

• A purpose-driven workplace with passionate teammates who want to help patients and make a positive difference in the world

Key Responsibilities:
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)

• Maintain and continuously improve an ISO 13485 / MDSAP-compliant QMS

• Apply a pragmatic approach: ensuring compliance without unnecessary complexity

• Ensure audit readiness across:

• Document control

• Training systems and records

• Equipment and process controls

• Supplier quality

• CAPA and complaint handling

• Identify system gaps and implement scalable, practical solutions

• 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

• Partner cross-functionally with Operations to minimize disruption

• Support validation and readiness of the new facility
Audit & Compliance Leadership

• Lead preparation for the ISO 13485 surveillance audit

• Act as the primary QA contact during internal and external audits

• Strengthen audit readiness (e.g., training documentation, system gaps, UDI compliance)

• Set and track annual quality objectives with senior leadership

• Present KPIs, trends, and quality insights across the organization
Product & Design Quality

• Support Design Controls (requirements, risk management)

• Develop and implement test strategies and validation plans

• Partner with Engineering to balance speed, compliance, and practicality

• Lead Quality Reviews with Operations and Engineering to drive continuous improvement
Supplier & Manufacturing Quality

• 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

• Corrective actions

• Timely closure

• 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.

Why this role, and why now?
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…