Sr. Specialist, QA

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Skills you'll use

What you'll do

• 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 FDA regulations, EU MDR, ISO 13485, and other international regulatory frameworks.
• Monitor changes in regulatory requirements and assess potential impacts on regulatory operations processes and systems.
• Regulatory Data Management- Maintain, review, and manage regulatory data within internal systems and regulatory databases.
• Conduct technical review, remediation, and verification of regulatory data to ensure completeness, accuracy, consistency, traceability, and compliance.
• Support regulatory submissions and registrations through data preparation and maintenance activities, including databases such as GUDID, EUDAMED, and other global regulatory systems.
• Systems, Reporting & Analytics
• Support administration, enhancement, and effective utilization of regulatory information management systems and other digital tools supporting regulatory compliance.
• Develop and maintain reports, dashboards, and performance metrics utilizing tools such as Excel, Power BI, and similar reporting platforms.

Who can apply

• Education: Bachelor's degree in Regulatory Affairs, Life Sciences or a related field.
• Experience: Minimum 4-8 years of experience in Regulatory Affairs, Regulatory Operations, Regulatory Data Management, Quality Systems, or a related function within the medical device, pharmaceutical, biotechnology, or other regulated industry.
• Technical Knowledge: Working knowledge of FDA regulations, including Quality Management system regulation.
• Advanced proficiency with Microsoft Excel; experience with analytical tools preferred.

About Cardinal Health

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