Director, Clinical Affairs & Regulatory Strategy

Regulatory Toolkit; Brea (CA); On-site; USD 177,000 - 217,000; Full time

Job summary

Envista, through its Kerr operating company, seeks a Director of Clinical Affairs to define and execute the clinical strategy across restorative and disinfection product areas. The role oversees clinical evidence, lifecycle management, and regulatory expectations in a risk-based, evidence-driven approach, including CERs, PMCF, and PMS reports.

Located in Southern California with onsite presence 4 days a week; a strong medical/dental background and FDA/ISO experience are essential for leading

Qualifications

• Doctor of Dental Science (US DDS) or similar degree required.
• Active Dental license in the US or Europe required.
• 10+ years in clinical affairs or clinical development with leadership experience.

Responsibilities

• Provide leadership for clinical strategy and vision, overseeing trials and regulatory compliance.
• Develop and execute medical/dental strategy aligned with product lifecycle stages.
• Support regulatory submissions with regulatory affairs and ensure ISO 14155/Good Clinical Practices.

Skills

Communication skills

Regulatory knowledge

Project management

Cross-functional leadership

MS Office

Education

DDS or similar degree

Job description

Envista, through its Kerr operating company, seeks a Director of Clinical Affairs to define and execute the clinical strategy across restorative and disinfection product areas. The role oversees clinical evidence, lifecycle management, and regulatory expectations in a risk-based, evidence-driven approach, including CERs, PMCF, and PMS reports.

Located in Southern California with onsite presence 4 days a week; a strong medical/dental background and FDA/ISO experience are essential for leading