KMO Director, Clinical Affairs (Brea, CA)
Core
Senior leadership role bridging clinical strategy, medical/dental affairs, and regulatory functions to define and execute clinical strategy for restorative, endodontics, and disinfection products.
Role type
Director, Clinical Affairs (Medical/Dental Devices)
Builds
Clinical evidence packages, PMCF/PMS reports, and regulatory dossiers for medical devices.
Domain
Medical Devices / Dental / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical strategy definition, regulatory compliance (FDA, EU MDR, ISO 13485), clinical trial oversight, CRO/vendor management, post-market surveillance, scientific publication leadership, budget management, cross-functional leadership.
Preferred skills
Advanced degree (MS, MSD, PhD), experience with IDE/IND/PMA/510(k) submissions, Key Opinion Leader relationship building, innovation pipeline evaluation.
Technologies
Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Provide leadership for clinical strategy and vision; oversee clinical trials, data review, and safety monitoring; support regulatory submissions; manage CROs and study sites; identify gaps in clinical evidence and plan studies; lead scientific publications and presentations; monitor patient safety and risk/benefit; establish SOPs and best practices.
Seniority
Director, strategic leadership with hands-on oversight