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 setting

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 Fast‑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

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