Dental Clinical Research Lead – Onsite, MDR/ISO Expert

Regulatory Toolkit; Brea (CA); On-site; USD 126,000 - 153,000; Full time

Job summary

Envista’s Kerr division seeks a Clinical Research Manager to lead US clinical usability studies across Restorative, Endodontics and Preventive dental products. You will ensure all studies align with GCP, ISO 14155, and applicable medical device regulations while coordinating with marketing, R&D and clinical teams on strategy and launches.

You will manage regulatory documents (CERs, IFU, uFMEAs, PMS plans, SSCPs), oversee vendors, and travel up to 20%.

Qualifications

• Bachelor’s in Dental Hygiene or, DMD, DDS, or MD degrees.
• 5+ years of relevant dental experience required (clinical or corporate).
• Experience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP.
• Ability to travel domestically and internationally up to 20%.

Responsibilities

• Design, organize, and execute clinical studies for new and existing dental products in accordance with Good Clinical Practices and ISO 14155.
• Develop and execute design validation protocols for new product development to ensure that the product meets user needs.
• Analyze the results and generate reports of design validations and clinical studies.
• Assist with essential clinical investigation document preparation for IRB approval.
• Participate in identification, evaluation, and selection of clinical study sites and investigators.
• Prepare, review and audit Informed Consent Forms and Case Report Forms of study subjects.
• Interface with clinicians/investigators and clinical research test sites
• Train personnel for clinical study execution
• Prepare, distribute, and reconcile devices for clinical evaluation.
• Serve as a core team member with marketing, R&D and clinical teams in new product development, and contributing to strategy, design inputs, and successful product launches.
• Actively contribute to the innovation pipeline by identifying opportunities, evaluating concepts, and supporting end-to-end product development.

Skills

Clinical research

Regulatory compliance

GCP ISO 14155

Vendor management

Cross-functional

Medical devices

Education

Bachelor’s in Dental Hygiene

DMD/DDS/MD

Tools

Microsoft Office

Job description

Envista’s Kerr division seeks a Clinical Research Manager to lead US clinical usability studies across Restorative, Endodontics and Preventive dental products. You will ensure all studies align with GCP, ISO 14155, and applicable medical device regulations while coordinating with marketing, R&D and clinical teams on strategy and launches.

You will manage regulatory documents (CERs, IFU, uFMEAs, PMS plans, SSCPs), oversee vendors, and travel up to 20%.