Regulatory Affairs Quality Assurance Lead
Job in
Burnaby, BC, Canada
Listed on 2026-09-19
Listing for:
Jobtailor
Full Time
position Listed on 2026-09-19
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager, Quality Engineering
Job Description & How to Apply Below
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
• Strong 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.
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