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 - 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.#J-18808-Ljbffr