Quality Assurance / Regulatory Affairs Manager

Job summary

Lead and develop the multidisciplinary Quality team while maintaining and improving the ISO 13485 and MDSAP-aligned Quality Management System. Oversee audits, CAPA, risk management, regulatory compliance, product release, complaint handling, and post-market activities.

Job details

WE'RE HIRING! QUALITY ASSURANCE & REGULATORY AFFAIRS MANAGER Location: Markham, Ontario | 100% On-Site Employment Type: Full-Time, Permanent Industry: Medical Devices Salary: $110,000–$125,000 CAD annually ABOUT THE OPPORTUNITY Kelly Services is recruiting an experienced Quality Assurance & Regulatory Affairs (QA/RA) Manager on behalf of one of our clients, an established medical device manufacturer located in Markham, Ontario. This is an exciting opportunity for an experienced quality leader to oversee Quality Engineering, Quality Systems, Regulatory Affairs, and Quality Control while driving regulatory compliance, operational excellence, and continuous improvement. Reporting to the Senior Director, Global Quality Operations, you will lead the Quality team, oversee the effectiveness of the Quality Management System (QMS), and serve as the site's ISO 13485 Management Representative and primary Health Canada regulatory contact. WHAT YOU WILL DO Lead, coach, and develop the Quality team across Quality Engineering, Quality Systems, Regulatory Affairs, and Quality Control. Manage and continuously improve the ISO 13485:2016 and MDSAP-aligned Quality Management System. Lead internal and external audits, including MDSAP, Health Canada, and customer audits. Oversee CAPA, root cause investigations, nonconformances, supplier quality, and corrective actions. Ensure compliance with Health Canada Medical Devices Regulations (SOR/98-282), including licensing and post-market reporting. Oversee product and process risk management in accordance with ISO 14971. Support process validation (IQ/OQ/PQ), design changes, and design transfer activities. Manage quality inspections, product release, calibration, and manufacturing quality activities. Oversee complaint handling, post-market surveillance, recalls, and regulatory reporting. Collaborate with Manufacturing, Engineering, and senior leadership to strengthen quality performance and compliance. WHAT WE'RE LOOKING FOR Required Qualifications Bachelor's degree in Engineering, Science, or a related technical field, or an equivalent combination of education and experience. Minimum 7 years of progressive experience in medical device Quality Assurance and/or Regulatory Affairs. Demonstrated experience managing quality professionals and/or supervisors. Strong knowledge of ISO 13485, MDSAP, and Health Canada Medical Devices Regulations. Experience managing QMS activities, internal and external audits, CAPA, and root cause investigations. Knowledge of medical device regulatory compliance, licensing, and post-market reporting. Strong communication, problem-solving, organizational, and leadership skills. Ability to work 100% on-site in Markham, Ontario. Preferred Qualifications ASQ certification (CQE, CQA, CMQ/OE) or RAPS Regulatory Affairs Certification (RAC). ISO 13485 Lead Auditor training or certification. Lean Six Sigma certification. Experience with EU MDR 2017/745 and international medical device regulatory requirements. Experience with supplier quality, ISO 14971 risk management, and manufacturing quality operations. COMPENSATION & WORK ENVIRONMENT Annual Salary: $110,000–$125,000 CAD Full-time, permanent position. 100% on-site at the Markham, Ontario facility. Combination of office and manufacturing floor responsibilities. Approximately 10% travel for audits, supplier visits, and corporate activities. Opportunity to lead a multidisciplinary Quality team and contribute directly to product safety, regulatory compliance, and operational performance. INTERESTED IN THIS OPPORTUNITY? Are you an experienced medical device quality professional looking for your next career opportunity? Or perhaps you know someone who would be a great fit? I'd love to connect! Apply directly, reach out to me through LinkedIn, or feel free to share this opportunity with someone in your professional network. Sabrina Olivier Bilingual Recruiter | Science, Engineering & Technology Kelly Services

What you’ll do

Lead and develop the multidisciplinary Quality team while maintaining and improving the ISO 13485 and MDSAP-aligned Quality Management System. Oversee audits, CAPA, risk management, regulatory compliance, product release, complaint handling, and post-market activities.

Requirements

Requires a bachelor's degree in Engineering, Science, or a related technical field, or equivalent education and experience, plus at least seven years of progressive medical device Quality Assurance and/or Regulatory Affairs experience. Candidates should have experience managing quality professionals and strong knowledge of ISO 13485, MDSAP, Health Canada regulations, audits, CAPA, and post-market compliance.

Listed skills

• Quality assurance · Preferred
• Root Cause Analysis · Preferred
• Team Leadership · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Quality Assurance
• Regulatory Affairs
• Quality Management Systems
• ISO 13485
• MDSAP
• Health Canada Regulations
• Audit Management
• CAPA
• Root Cause Analysis
• Supplier Quality
• ISO 14971 Risk Management
• Process Validation
• Complaint Handling
• Post-Market Surveillance
• Team Leadership
• Medical Device Compliance

Job areas

• Healthcare
• Management & Leadership
• Manufacturing
• Engineering
• Legal

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