Oversee the planning, writing, editing, and quality control of a wide range of clinical and regulatory documents, including technical documentation for CE-IVDR/MDR, summaries, and responses to notified body questions, but also could include clinical study protocols, clinical study reports (CSRs), Investigator's Brochures (IBs), and similar documentation, as needed by the Clinical Development teams. Collaborate effectively with cross-functional teams including CCOE Clinical Development, Biostatistics, Data Management and Operating Company partners in Regulatory Affairs, Quality Assurance, Medical & Scientific Affairs and R&D to gather necessary input and ensure scientific accuracy and consistency across documents.