New · posted Nov 1
Envista · Medical Devices
KMO Director, Clinical Affairs
- Brea, CA
- On-site
- Full-time
- Director
The role
Director, Clinical Affairs is a senior-level leadership position that bridges clinical strategy, medical/dental affairs, and regulatory/commercial functions.
The Director, Clinical Affairs 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.
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.
What you need
- Doctor of Dental Science (US DDS is required) or similar degree (MS, MSD, PhD) required.
- Possess an active Dental license in the US or Europe required.
- 10+ 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.
IND123
What you'll do
- 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.
Pay and benefits
$177,300 – $216,700 a year
Employer providedTarget 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
Annual performance bonus
Medical/dental/vision benefits
401K match
Where you'll work
Brea, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Brea, CA
Equal opportunity, accessibility and legal noticesEnvista's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
This role's midpoint is 9% below the US median for Clinical Affairs roles at this level.
This roleEmployer provided
Director roles in the US5 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $177,300 | — | $216,700 |
| All US (middle half) | $197,000 | $216,000 | $238,500 |
This role: Envista's own published range. Comparisons: the base pay employers published on open Clinical Affairs roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Affairs
The general path across 18 open Clinical Affairs roles on Regulatory Jobs, with the titles they carry most. Not Envista's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 37 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- Clinical trial conduct7
- GMP and compliance5
- Documentation and SOPs4
- Regulatory submissions3
- Investigations and CAPA2
- Quality systems and risk2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification for medical devices
Company hiring pulse
Envista on Regulatory Jobs
- 11
- Open roles
- 10
- Distinct roles
- 7
- Locations
By discipline
- Quality5 45%
- Regulatory4 36%
- Clinical2 18%
By level
- Associate & Specialist5 45%
- Manager4 36%
- Director1 9%
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KMO Director, Clinical Affairs at Envista
Open until filled. $177K–$217K a year, employer provided.