Director, Clinical Affairs: Strategy & Trials

Kerr Dental; Brea (CA); On-site; USD 177,000 - 217,000; Full time

Job summary

Kerr, operating under Envista, seeks a Director of Clinical Affairs to bridge clinical strategy, medical/dental affairs, and regulatory functions. This senior leader will own the clinical evidence lifecycle, CERs/PMCFs, and PMS for regulatory submissions and market access initiatives.

They will drive end-to-end product development, identify opportunities, and collaborate with R&D, marketing, and quality teams to ensure robust safety and performance data throughout the product lifecycle.

Qualifications

• DDS or similar degree with advanced degree (MS, MSD, PhD) required (US DDS is required).
• 5+ years in clinical affairs or clinical development with leadership experience.
• Experience supporting FDA, ISO 13485, MDSAP, EU MDR, and GMP compliance.

Responsibilities

• Lead clinical strategy, trials, and regulatory compliance.
• Develop medical/dental strategy across product lifecycle stages.
• Support regulatory submissions and provide input for IDE/IND/PMAs/510(k) or CE dossiers.
• Oversee trial execution, data review, safety monitoring, and protocol development.
• Collaborate with R&D, Marketing, and Quality to align evidence plans.
• Lead publications, abstracts, and presentations; ensure data supports claims.

Skills

Clinical strategy

Regulatory knowledge

Project management

Cross-functional leadership

Medical/dental expertise

Communication skills

MS Office

Education

DDS or equivalent with advanced degree

Tools

Microsoft Office

Job description

Kerr, operating under Envista, seeks a Director of Clinical Affairs to bridge clinical strategy, medical/dental affairs, and regulatory functions. This senior leader will own the clinical evidence lifecycle, CERs/PMCFs, and PMS for regulatory submissions and market access initiatives.

They will drive end-to-end product development, identify opportunities, and collaborate with R&D, marketing, and quality teams to ensure robust safety and performance data throughout the product lifecycle.