The Compliance Manager will report to the Director of Quality in an FDA-approved manufacturing facility in E.TN. The Compliance Manager will have multi-site responsibility overseeing the Audit program to ensure company is compliant with FDA regulations (820), permits, labeling, ISO-13485 requirements, and international standards for medical devices.
The Compliance Manager will evaluate changes to the regulatory compliance of document, product, process, and test methods. Will also review customer complaints, perform internal & external audits, and review labeling for compliance.
The position requires a BS degree and CQA certification is preferred. Must have at least 3 years experience in Quality Management in an FDA-approved facility. Knowledge of US and International medical device regulatory requirements is a must.