United States of America, California, Brea United States of America, California, Pomona Full time

R5027047

• Job Description:

• JOB SUMMARY

• : Director, Clinical Affairs is a senior-level leadership position that bridges clinical strategy, medical/dental affairs, and regulatory/commercial functions.

The Sr. Clinical Research Manager is responsible for defining and executing the overall clinical strategy in Restorative, Endodontics, Orascoptic and Disinfection and making sure that all studies follow regulatory standReards for medical devices. Actively contribute to the innovation pipeline by identifying opportunities, evaluating concepts, and supporting end-to-end product development. Under the EU Medical Device Regulation (MDR 2017/745), the Director of Clinical Affairs will own and oversee the clinical evidence, lifecycle management, and regulatory expectations in risk-focused evidence driven approach for CER's, PMCF's and PMS reports.

• PRIMARY DUTIES & RESPONSIBILITIES

• : + Provide leadership for clinical strategy and vision, overseeing clinical trials, scientific direction, cross‑functional collaboration, and regulatory compliance.

+ Develop and execute medical/dental strategy aligned with product lifecycle stages, ensuring alignment with clinical development, regulatory, and commercial goals. + Support regulatory submissions with regulatory affairs and ensure compliance with clinical and regulatory standards. Provide clinical input for

IDE, IND, PMA, 510

(k), or CE marking dossiers. + Oversee clinical trial execution, data review, safety monitoring, and protocol development, often in collaboration with clinical development, biostatistics, and medical operations in accordance with Good Clinical Practices and

ISO 14155.

+ Serve as the primary medical/dental contact for investigators, ethics committees, and regulatory authorities; represent the company in advisory boards and scientific meetings. + Partner with commercial, and product management teams to integrate medical/dental insights into market access and go-to-market strategies. + Manage budgets, study progress, timelines, and track performance metrics, to ensure efficient trial execution. + Manage CROs, study sites, investigators, and vendors. + Identify gaps in clinical evidence and plan studies to address them. + Develop and execute clinical evidence plans (pre- and post-market). + Conduct post-market clinical follow-up (PMCF) or Phase IV studies. + Support ongoing safety and performance evaluations. + Serve as a clinical voice in executive decision-making. + Actively contribute to the innovation pipeline by identifying opportunities, evaluating concepts, and supporting end-to-end product development. Evaluate new technologies, indications, or acquisitions. + Identify and establish relationships with research institutions, universities, industry experts and Key Opinion Leaders as needed for driving clinical affairs activities. + Lead scientific publications, abstracts, and presentations. + Ensure data supports claims, safety, and effectiveness. + Monitor patient safety and risk/benefit throughout clinical programs. + Review adverse events and ensure proper reporting + Contribute to risk management and post-market surveillance activities + Cross-functional collaboration with R D/Product Development, Marketing and Quality & Regulatory teams. + Establish processes, SOPs, and best practices.

• Job Requirements:

• + Doctor of Dental Science (DDS) or similar degree with advanced degree (MS, MSD, PhD) required (US DDS is required).

+ 5+ years in clinical affairs, medical affairs, or clinical development, with leadership experience in managing clinical programs or medical/dental strategy. + Experience supporting compliance with

FDA, ISO 13485, MDSAP, EU

MDR, and GMP.

• SKILLS & ABILITIES

• + Outstanding communication skills, detail-oriented and efficient in time management.

+ Strong medical expertise, regulatory knowledge, project management, and cross-functional leadership. + Strong interpersonal and teamwork skills. + Experience using Microsoft Office (Word, Excel, Power Point) to prepare charts, tables, forms, reports, and presentations. + Ability to work both independently and as part of a team. \#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. $177,300 - $216,700

• 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 .