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 robust 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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📌 Regulatory Affairs Quality Assurance Lead (British Columbia)
🏢 Jobtailor
📍 British Columbia