"Alerted.org

Job Description:

Position Summary:

The **Clinical Research Manager** will be primarily responsible for planning and execution of clinical validation activities related to specific projects including execution of plans and protocols for performing internal (in-house under simulated conditions) and external (in the customers' use environment) design validation and creating documentation required by FDA/MDR (Medical Device Regulation), Standard Operating Procedures, Good Clinical Practice and other regulations.

Essential Duties and Responsibilities:

+ Lead sustaining projects by identifying opportunities for design enhancements and implement changes to optimize product functionality and manufacturability.

+ 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.

+ 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. (formative & summative).

+ Create 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 510k submission and CE tech files.

+ Provide clinical input to the development team to determine feasibility of new products.

+ Be able to travel approximately 20% of the time

**Incidental Duties:** The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Job Requirements:

Minimum Qualification:

+ Bachelors in Science degree; DDS, DMD, or MD required

+ Minimum of two years of clinical experience in medical device, dental, and/or healthcare related environment.

+ Knowledge of FDA, GCP and ISO guidelines highly preferred.

+ Basic understanding of medical device product development processes required.

Preferred:

+ Ability to work independently and within a team environment required.

+ Strong interpersonal and collaborative teamwork abilities required.

+ Ability to build effective cross-departmental partnerships required.

+ Confidence, tact, and resourcefulness in handling various situations required.

+ Flexibility to adapt in a fast-paced, changing environment required.

+ Excellent communication, attention to detail, and time management skills required.

+ Effective presentation and public speaking skills required.

+ Strong verbal and technical writing skills in English required.

+ Proficiency in Microsoft Office (Outlook, Word, Excel) and ability to create charts, reports, and presentations required.

+ Strong analytical thinking and data-driven decision-making skills required.

+ Experience managing complex projects required.

**Physical Demands:** Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

+ Constantly sits.

+ Frequently uses hands and fingers.

+ Occasionally walks and stands.

+ Rarely bends and stoops.

+ Occasionally reaches up/down with arms.

+ Occasionally lifts and/or moves up to 5 lbs.

\#LI-RJ1

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.

$99,400 - $149,100

Operating Company:

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://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

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 is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.

Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com .