Program management involves a comprehensive overview of all your projects.
- manage product development projects, including budget, timeline, and suppliers
- coordinate product development / design control documentation and deliverables, ensuring FDA and ISO compliance
- assist with design history files (DHF), 510(k) submissions, technical files, and other regulatory submissions
- ensure product risk management practices and documentation are compliant and streamlined
- manage internal projects and teams, including quality system initiatives, corrective & preventive action (CAPA) implementation
- conduct internal auditing