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
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.
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