Dental Clinical Research Manager - MDR/ISO Compliance

Kerr Dental; Brea (CA); On-site; USD 126,000 - 153,000; Full time

Job summary

Kerr Dental is seeking a Clinical Research Manager to lead US clinical usability studies for restorative, endodontics, and preventive products. You will ensure regulatory compliance with medical device standards across studies and manage vendor relationships with finance and legal.

You will work with marketing, R&D, and clinical teams on product development, strategy, and launches, while contributing to the innovation pipeline and end-to-end development processes.

Qualifications

• DDS or similar degree is required.
• 5+ years of dental experience is preferred.
• Experience with FDA, ISO 13485, MDSAP, EU MDR, and GMP compliance is required.

Responsibilities

• Design, organize, and execute clinical studies for dental products per GCP and ISO 14155.
• Develop and execute design validation protocols for new product development.
• Prepare and audit informed consent forms and case report forms.

Skills

Strong communication

Detail-oriented

Time management

Medical device development knowledge

Education

DDS or similar degree

5 years dental experience

Tools

Microsoft Office

Job description

Kerr Dental is seeking a Clinical Research Manager to lead US clinical usability studies for restorative, endodontics, and preventive products. You will ensure regulatory compliance with medical device standards across studies and manage vendor relationships with finance and legal.

You will work with marketing, R&D, and clinical teams on product development, strategy, and launches, while contributing to the innovation pipeline and end-to-end development processes.