KMO Director, Clinical Affairs (Brea, CA)
Core
Senior leadership role bridging clinical strategy, medical/dental affairs, and regulatory/commercial functions to define and execute clinical strategy for medical devices.
Role type
Senior Director, Clinical Affairs
Builds
Clinical evidence, lifecycle management, and regulatory dossiers for medical devices
Domain
Medical Devices / Dental
Required skills
Clinical strategy, regulatory compliance (FDA, EU MDR), clinical trial execution, post-market surveillance, stakeholder management, budget management, CRO/vendor management, scientific publications
Preferred skills
Innovation pipeline evaluation, technology assessment, academic/investigator relationships
Technologies
Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Provide leadership for clinical strategy and vision; Develop and execute medical/dental strategy aligned with product lifecycle; Support regulatory submissions (IDE, IND, PMA, 510(k), CE marking); Oversee clinical trial execution, data review, and safety monitoring; Manage budgets, study progress, and timelines; Identify gaps in clinical evidence and plan studies; Lead scientific publications and presentations; Monitor patient safety and risk/benefit; Cross-functional collaboration with R&D, Marketing, and Quality teams.
Seniority
Senior, hands-on IC with leadership