Clinical Research Manager

Position Summary

The Clinical Research Manager is responsible for managing all US clinical usability studies for Restorative, Endodontics, and Preventive dental products. The role ensures that all studies follow regulatory standards for medical devices and manages vendor relationships with finance and legal. This individual serves as a core team member with marketing, R&D, and clinical teams in new product development, contributing to strategy, design inputs, and successful product launches.

The position also actively contributes to the innovation pipeline by identifying opportunities, evaluating concepts, and supporting end-to-end product development. All clinical documentation for new products that need to comply with MDR regulations, including CERs, IFUs, uFMEAs, PMS plans, and SSCPs, will be managed at this level.

• 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 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.
• Track, review, and prepare study‑specific information utilizing databases, spreadsheets, and other tools for reporting status updates to the team; maintain study‑related databases.
• Design and execute Human Factor Usability studies.
• Create and update Risk Management Files (uFMEAs and Risk Tables according to ISO 14971).
• Support generation of Clinical Evaluation Reports and Post‑Market Clinical Follow‑Up protocols to assess safety and efficacy of medical devices in compliance with applicable regulations.
• Write and update Instructions for Use for dental products.
• Collaborate with cross‑functional team members, providing input to the DHF for 510(k) submission and CE tech files.

• Doctor of Dental Science (DDS) or similar degree plus 5 years of relevant dental experience.
• Preferred:
  Dentist or Hygienist.
• Experience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP.
• Must reside within a commutable distance to Brea, CA or Pomona, CA; this is a full‑time, non‑remote role.
• Ability to travel domestically and internationally.
• Strong communication skills, detail‑oriented, and efficient in time management.
• Basic knowledge of medical device development processes.
• Ability to work in a diverse team, prioritizing and planning own workload.
• Experience using Microsoft Office (Word, Excel, Power Point) to prepare charts, tables, forms, reports, and presentations.

$125,500 - $153,400. Actual compensation packages take into account geographic location, skill sets, relevant education and certifications, depth of experience, performance, and other factors. The total compensation package may also include an annual performance bonus, medical/dental/vision benefits, 401(k) match, and other applicable plans.

Kerr Envista and all Envista Companies are equal‑opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://(Use the "Apply for this Job" box below)..

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