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

#J-18808-Ljbffr

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