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
- Solid 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