Senior Regulatory Affairs Specialist
- Provides oversight of Cerner Quality System components.
- Provides monitoring, oversight, support, and training of Corrective and Preventive Action (CAPA) system, Compliant Management and Document management system.
- Authors and reviews regulatory communications and regulatory reports.
- Assists with Internal and External audits (e.g., provides interview support, participates in follow up meetings, and reviews audit reports)
- Proactively identifies process improvements and system enhancements.
- Assists in the development and processing of 510K and CE Marking submission materials