KMO Clinical Research Manager (Brea/Pomona, CA)

United States of America, California, Brea \| United States of America, California, Pomona R5026883 United States of America Science **Job description** **JOB SUMMARY**: The **Clinical Research Manager** is responsible for managing all US clinical usability studies for Restorative, Endodontics and Preventive, making sure that all studies follow regulatory standards for medical devices in addition and managing vendor relationships with finance and legal. He/She serves 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. All clinical documentation for new products that need to comply with MDR regulations including but not limited to CER’s, IFU’s, uFMEA’s, PMS plans and SSCP’s will also be managed at this level. *Candidates must reside within a commutable distance to both Brea, CA and Pomona, CA, as the office location will be relocated from Brea to Pomona in the near future. This is not a hybrid or remote opportunity and requires onsite presence 4 days per week.* **PRIMARY DUTIES \& 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. * 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. * Participate in the innovation funnel for new products and be part of the core team members for new product development. * Write and update Instructions for use for dental products * Collaborate with cross functional team members, providing input to the DHF for 510k submission and CE tech files. **Job requirements** * Bachelor’s in Dental Hygiene or, DMD, DDS, or MD degrees. * 5\+ years of relevant dental experience required (clinical or corporate). * Possesses an active dental license in US or Europe. * Experience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP. * Ability to travel domestically and internationally up to 20%. **PREFERRED QUALIFICATIONS:** * 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 \#LI\-SC1 IND123 **Target Market Salary Range:** Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans. $125,500 \- $153,400 **Operating Company:** Kerr Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee\-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully\-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place. 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: https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf Read more Kerr Operating Company: Kerr Location: United States of America, California, Brea \| United States of America, California, Pomona Date Posted: July 19 , 2026 Req Number: R5026883 Benefits **Caring for our employees and their families** ----------------------------------------------- **Health \& Wellbeing** We offer comprehensive programs designed to support the health and wellbeing of our employees and their families. From medical coverage to wellness resources, we prioritize helping our people thrive both physically and mentally. **Retirement \& Financial Benefits** We are committed to supporting our employees’ financial wellbeing—today and in the future. Our competitive compensation and retirement or savings programs are designed to help employees build financial confidence at every stage of their careers. **Life \& Disability Insurance** We provide benefits that help protect employees and their loved ones when it matters most. Depending on location, our life and disability programs offer valuable financial security and added peace of mind during unexpected life events. **Paid Time Off** We know that time away from work is essential for rest, balance, and personal priorities. Our paid time off, holidays, and leave programs are designed to give employees the flexibility to recharge and take care of what matters most. **Learning \& Career Development** We believe in investing in our people. Through learning opportunities, development programs, and career growth pathways, we empower employees to build meaningful careers and continue growing with us. **Our hiring process** ---------------------- At Envista, we’re committed to helping you feel confident and prepared every step of the way. Our interview guide will walk you through what to expect, how to showcase your strengths, and how you can make an impact by helping us champion dental professionals and improve lives. **1\. Application Review** After you apply, our team will review your experience and qualifications. If your background aligns with the role, a recruiter will reach out to discuss the opportunity and next steps. **2\. Interviews** You’ll meet with members of the hiring team to learn more about the role and share your experience. Depending on the position, this may include multiple conversations focused on your skills, experience, and how you can make an impact. **3\. Offer Decision** If selected, you’ll receive an offer outlining compensation, benefits, and other details. Our team will guide you through the process and answer any questions to help you make an informed decision. **4\. Onboarding** Once you join, we’ll support your transition with onboarding resources and guidance to help you get started and feel connected from day one.