Become a Regulatory Affairs Quality Assurance Lead, ensuring compliance with ISO 13485 standards. This hands-on role demands expertise in regulatory documentation and team leadership.

You will spearhead Quality Assurance and Regulatory Affairs initiatives, ensuring timely completion of key activities. With a strong focus on building capabilities within your team, you will also maintain audit readiness and continuously improve a compliant Quality Management System.

Key Responsibilities: • Oversee Quality Assurance and Regulatory Affairs operations • Prepare for ISO 13485 surveillance audits • Build cross-functional relationships across departments • Drive CAPA investigations and quality reviews • Maintain FDA regulatory compliance for products

Requirements: • 5–10+ years in Quality Assurance leadership • Robust experience in controlled manufacturing environments • Proven capabilities in QMS ownership and supplier quality • Excellent problem-solving skills • Experience with MDSAP or FDA regulatory operations preferred

Enhance quality and regulatory strategies as a leader in the medical device industry.

📌 Regulatory Affairs Quality Assurance Lead (Burnaby)
🏢 Jobtailor
📍 Burnaby