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 chance 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 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. We are already in 75+ U.S. hospitals (including more than 20% of all Level 1 Trauma Centers), have a high double‑digit growth rate, and are backed by a deep roster of Canadian healthtech investors. Entering 2026, we are ready to accelerate product development and scale up US sales and medical education to set a new standard of care in our target procedures.

5-10+ years in Quality Assurance and Regulatory Assurance leadership within medical devices or an equivalent controlled manufacturing environment

(ISO 13485 environment or equivalent)

Experience owning the functions

Strong working knowledge of:

ISO 13485 or equivalent

Proven experience with:

Audits (internal & external)





CAPA systems

Supplier quality

QMS ownership

Background in a technical field (engineering, science, or equivalent)

Strong communication skills (including customer‑facing quality discussions)

Ability to operate in a fast‑paced, scaling environment

Nice-to-Have

Experience with MDSAP and/or FDA regulatory requirements

Background with Class I/II devices, sterile products, or orthopaedics

ISO 13485 or ISO 9001 Lead Auditor certification

Experience supporting U.S. regulatory operations (e.g., UDI submissions)

Experience supporting or leading facility changes, audits, or scaling environments

Experience with internationally recognized standards for medical device development (e.g., ISO10993, ISO14971, IEC 60601, ISO 11135, ISO 11137)

Desired Capabilities and Traits

Hands‑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 unnecessary

Detail‑oriented: You ensure systems hold up under audit scrutiny

Cross‑functional partner: You build trust across Engineering, Ops, and Supply Chain

Balanced mindset: You protect quality without slowing the business

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

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.

Competitive Salary
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.

About Arbutus Medical Inc.
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 simple 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 SwiftKit, a procedure kit that streamlines revision amputations of fingers and toes. 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.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.

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📌 Manager, Quality Assurance & Regulatory Affairs - Arbutus Medical (British Columbia)
🏢 BLANKSLATE Partners
📍 British Columbia