Regulatory Affairs & Quality Manager

The Regulatory Affairs & Quality Manager maintains and improves certifications such as ISO 13485, as well as other relevant standards and regulations. This position is responsible for maintaining and improving certifications such as ISO 13485, as well as other relevant standards and regulations. The manager will oversee the Quality Management System (QMS), ensuring compliance and providing guidance, support, and training to the organization. Additionally, the manager will report to senior management on the status of ISO systems and certifications. Responsibilities include interfacing with regulatory bodies, coordinating submissions, monitoring regulations, overseeing QMS, participating in adverse events and recalls, ensuring company compliance, conducting audits, developing training, supporting improvement projects, and implementing eQMS.