Lead day-to-day Quality Assurance and Regulatory Affairs activities
Set priorities, clarify accountabilities, and ensure critical QA/RA activities are completed on time
Coach and develop team members and build capability across the function
Establish goals, KPIs, and expectations for QA/RA
Directly execute critical QA/RA work as a hands‑on leader
Build cross-functional relationships with Engineering, Operations, Supply Chain, Product, Commercial, and senior leadership
Build and scale the QA/RA function, including identifying resource needs and hiring the team
Maintain and continuously improve an ISO 13485/MDSAP‑compliant QMS
Ensure audit readiness across document control, training, equipment and process controls, supplier quality, CAPA, and complaint handling
Identify QMS gaps, implement scalable solutions, conduct CAPA trend analysis, and report insights
Ensure QMS compliance during the facility relocation to Burnaby
Update site documentation, risk assessments, and processes; support facility validation and readiness
Lead ISO 13485 surveillance audit preparation and act as primary QA contact during audits
Track quality objectives and present KPIs, trends, and quality insights to leadership
Support design controls, risk management, test strategies, and validation plans
Lead quality reviews with Operations and Engineering
Partner with Supply Chain on supplier qualification, monitoring, and performance
Lead CAPAs and complaint investigations, including root cause analysis, corrective actions, and timely closure
Coordinate regulatory activities, product registrations, establishment registrations, listings, and regulatory documentation
Maintain FDA UDI/GUDID requirements and regulatory database submissions




Monitor regulatory changes and assess impacts on products, processes, and the QMS
Support regulatory submissions, registrations, renewals, and change assessments
Incorporate regulatory requirements into product development, manufacturing, supplier, and quality processes
Assess regulatory implications of product and design changes
Maintain audit‑ready regulatory records and advise internal teams on compliant regulatory paths
Requirements 5–10+ years in Quality Assurance and Regulatory Assurance leadership within medical devices or an equivalent controlled manufacturing environment
Experience in an ISO 13485 environment or equivalent
Experience owning the QA/RA functions
Strong working knowledge of ISO 13485 or equivalent
Proven experience with internal and external audits
Proven experience with CAPA systems
Proven experience with supplier quality
Proven experience with QMS ownership
Background in a technical field such as engineering, science, or equivalent
Strong communication skills, including customer‑facing quality discussions
Ability to operate in a fast‑paced, scaling environment
Experience with MDSAP and/or FDA regulatory requirements is nice‑to‑have
Background with Class I/II devices, sterile products, or orthopaedics is nice‑to‑have
ISO 13485 or ISO 9001 Lead Auditor certification is nice‑to‑have
Experience supporting U.S. regulatory operations,



such as UDI submissions, is nice‑to‑have
Experience supporting or leading facility changes, audits, or scaling environments is nice‑to‑have
Experience with internationally recognized medical device development standards, including ISO10993, ISO14971, IEC 60601, ISO 11135, and ISO 11137, is nice‑to‑have
Core Competencies Demonstrates extensive experience in Quality Assurance and Regulatory Affairs leadership within the medical device sector, with a strong focus on ISO 13485 compliance, CAPA systems, and audit readiness. Capable of building and scaling QA/RA functions while fostering cross‑functional collaboration and ensuring regulatory compliance.
Highest-signal resume keywords ISO 13485 Compliance
Quality Management System (QMS) Ownership
CAPA Systems Management
Regulatory Affairs Expertise
Internal and External Audits
Hard Skills Quality Assurance Leadership
Regulatory Documentation
Supplier Quality Management
Risk Management
Design Controls
Audit Preparation
CAPA Trend Analysis
Quality Objectives Tracking
Process Controls
Complaint Handling
Soft Skills Strong Communication Skills
Team Coaching and Development
Cross‑Functional Collaboration
Problem‑Solving
Adaptability in Quick‑Paced Environments
Certifications & Qualifications ISO 13485 Lead Auditor Certification
ISO 9001 Lead Auditor Certification
Industry Keywords Medical Devices
Controlled Manufacturing Environment
Class I/II Devices
Sterile Products
Internationally Recognized Medical Device Development Standards
Tools & Technologies ISO 13485
MDSAP
FDA UDI/GUDID
Regulatory Database Submissions
Document Control Systems

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📌 Manager, Quality Assurance – Regulatory Affairs (British Columbia)
🏢 Jobtailor
📍 British Columbia