Clinical Specialist

Role Overview: The Clinical Specialist plays a key role in advancing laser dentistry by leading clinical studies, optimizing laser parameters, and developing innovative, evidence-based applications for Class III hard tissue and Class II soft tissue lasers. This position is responsible for validating safety and efficacy, supporting clinician training and education, ensuring regulatory compliance, and analyzing clinical data to inform product development. Serving as a critical bridge between R&D engineering and clinical practice, the Clinical Specialist helps translate technical innovation into real-world clinical outcomes.

Key Responsibilities:

• Protocol Development: Develop and test new protocols for hard tissue cavity preparation, bony procedures (bone regeneration/decortication), and soft tissue management.
• Clinical Research & Studies: Design and implement clinical studies to evaluate the efficacy of Waterlase (Er,Cr:YSGG) in wound healing and periodontal therapy.

Training: Train dentists, hygienists, and assistants on Waterlase protocols and Epic Diode soft tissue procedures (bacterial reduction, gingival sculpting).

• Laser Implementation: Assist clinics with " operational mastery," setup, and workflow integration of devices to ensure consistent clinical results and procedural accuracy.

• Data Analysis & Publication: Analyze clinical data regarding laser performance—such as bacterial reduction (940 nm diode) or enamel adhesion—and publish findings in dental journals.
• Technology Advancement: Collaborate with engineering teams to refine fiber-optic delivery systems, optimize power settings, and improve safety features.
• Troubleshooting & Calibration: Perform routine maintenance, power output tests, and troubleshooting for Waterlase and diode fiber-optics.
• Regulatory Support: Generate technical communications, white papers, and data to support FDA 510(k) or Premarket Approval (PMA) updates. - Strong understanding of FDA and MDR regulations, GCP (Good Clinical Practice), and ISO 14155 standards.
• Safety & Compliance: Function as or train the Laser Safety Officer (LSO) to ensure compliance with FDA 21 CFR Part 1040.11 and ANSI Z136.3 standards.

Required Skills and Qualifications

Education: Bachelor’s degree in biomedical engineering, nursing, biological sciences, or a related field. Degree in Dental Science, Biomedical Engineering, or Physics.

• Experience: 2-5+ years in clinical research, specifically with medical devices. Previous experience with laser systems is highly preferred.
• Data Management: Experience using REDCap or similar Electronic Data Capture (EDC) systems preferred.
• Communication: Strong interpersonal skills to interact with clinicians and research participants. 

         Experience in clinical research methodology and dental laser physics.

• Knowledge of Class II and Class III medical device regulatory pathways. 

 Competencies preferred for Lasers

• Expertise in 940nm Diode: Soft tissue surgery, decontamination, and pain therapy preferred.
• Expertise in Er,Cr:YSGG (Waterlase): Hard/soft tissue ablation and cavity prep. preferred.