What Quality Assurance contributes to Cardinal Health

Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.

Quality Assurance develops and implements a compliant and cost-effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.

Job Summary
The Senior Specialist supports Regulatory Operations and advances global regulatory compliance through the management of regulatory processes, systems, data, and operational activities across the product lifecycle. This role serves as a key contributor to regulatory operations by ensuring the accuracy, integrity, and compliance of regulatory information used for global submissions, registrations, product maintenance,



and post-market activities.
The Senior Regulatory Affairs Specialist applies a strong understanding of medical device or pharmaceutical regulations, Quality Management system and regulatory operations processes to maintain compliant regulatory databases, support global market registrations, facilitate regulatory reporting, and drive process improvements. Working collaboratively with Regulatory Affairs, Quality, R&D;, Clinical, Manufacturing, Supply Chain, and IT, this individual contributes to the development of scalable and effective regulatory operations capabilities that support business objectives and regulatory compliance.

Responsibilities

Regulatory Operations & Compliance
- Support the development, implementation, and continuous improvement of regulatory operations processes, procedures, systems, and tools.
- Ensure compliance with applicable global regulatory requirements, including

📌 Sr. Specialist, QA (India)
🏢 Cardinal Health
📍 India