Dentsply Sirona · 2 weeks ago
Clinical Research Manager AI
Charlotte, NC
Full-time
Onsite
Mid, Senior Level
3+ years expDentsply Sirona is the world’s largest manufacturer of professional dental products and technologies. The Clinical Research Manager AI will be responsible for planning and executing clinical studies, ensuring compliance and safety for AI-enabled dental software, and collaborating with various departments to enhance product design and validation.
DentalEducationHealth CareManufacturingMedical Device
Responsibilities
Contribute to the design and execution of clinical studies required for medical devices that are sufficient for ISO 14155, EU MDR and FDA
Preparation and submission of clinical study documentation to Independent Ethics Committees/Review Boards and Regulatory Authorities
Registration of clinical studies in applicable databases
Monitoring of site, data management and follow up on time plan and budget
Study data analysis, preparation of clinical study reports and presentation of study data to internal and external parties
Serve as the primary dental subject matter expert for internal cross-functional teams developing AI-enabled dental software (e.g. CADe/CADx, AI visualization)
Provide clinical guidance on product design and validation, including study design for reader and standalone studies for AI models
Collaborate with R&D, Quality, Regulatory, and product marketing teams to ensure clinical relevance and safety of AI models and assist in methods to use AI internally for workflow efficiency
Stay up to date on AI regulations and AI in dentistry
Draft and review key sections of regulatory submissions and technical files such as CERs and study protocols (e.g. multi-reader multi case studies) for AI enabled medical device software
Qualification
Required
Higher education in natural science
Background in dentistry, research and/or clinical studies
3+ years prior experience in clinical affairs, regulatory affairs, and/or clinical research for AI/ML enabled medical device software. (SaMD/SiMD)
Knowledge of Medical Device regulations related to conduct of human clinical studies (e.g. ISO 14155, EU MDR, FDA, GDPR, Declaration of Helsinki, Good Clinical Practice (GCP) and EU AI Act)
Excellent project management and communication skills
Fluent English in writing and speaking
The ability to travel internationally up to 20 days yearly
Preferred
Experience working with Medical devices is preferable
Doctor of Dental Surgery DSD/Doctor of Medical Dentistry (DMD) is a merit
Company
Dentsply Sirona
Dentsply Sirona is a manufacturer of dental products and technologies.
10001+ employees
H1B Sponsorship
Dentsply Sirona has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (28)
2024 (14)
2023 (7)
2022 (14)
2021 (9)
2020 (16)
Funding
Current Stage
Public CompanyTotal Funding
$550M2025-06-05Post Ipo Debt· $550M
1987-08-21IPO
Leadership Team
Daniel Scavilla
President and Chief Executive Officer
Matthew Garth
Chief Financial Officer
Recent News
GlobeNewswire
2026-01-16
2026-01-16
Company data provided by crunchbase