Product Development Manager
REPORTING TO: Chief Executive Officer
Lead the development of new Cancer Diagnostic tests, post-discovery, through the regulated stages of commercial product development.
Lead a team of Product Development Scientists to successfully complete within strict timelines the Development cycle for new cancer diagnostic tests
Ensure compliance with Design Control procedures per FDA QSR and ISO13485, establishing and maintaining Design History Folders to capture outputs from key design stages and demonstrate traceability between Design Inputs and Design Outputs.
Maintain quality records throughout the development process to ensure regulatory approval and ongoing manufacturability of new products.
Liaise with Pathologists and Clinical Trial Design advisors to create appropriate Clinical Trial Design plans and manage successful execution of Clinical Studies
Liaise with external third parties, Oncologists, Pathologists, & Laboratory Scientists to ensure Developed tests meet Clinical acceptance criteria and end-user requirements
Provide support to Marketing & Sales to ensure all required Technical and scientific information is available in an understandable format to support the marketing efforts.