Quality and Regulatory Manager

This role leads quality and compliance programs for IVD products, ensuring regulatory adherence and driving product and process improvements across manufacturing, R&D, and commercial activities. The Quality and Regulatory Manager maintains the Quality Management System, serves as the Quality Management Representative, and oversees audits, CAPA, and regulatory submissions for global IVD products. The position requires strong expertise in FDA and ISO regulations, medical device experience, and the ability to collaborate effectively across teams to ensure continuous quality excellence.