Quality & Regulatory Specialist at VideaHealth

Boston, Massachusetts, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Dentistry, Medical Devices, AIIndustries

Requirements

Candidates must possess a Bachelor's Degree or higher and have at least 3 years of experience in a quality and regulatory role. Experience, certifications, or credentials in quality auditing, regulatory affairs, software quality assurance, or cybersecurity are required. Strong communication and collaboration skills with both external and internal stakeholders are essential, along with a strong technical or medical regulatory writing ability. Experience in developing, implementing, and monitoring Quality Management System (QMS) processes such as document control, CAPA, complaint handling, and training is necessary. Familiarity with cybersecurity and electronic protected health information (ePHI) processes, including knowledge of HITRUST, SOC2, HIPAA, and/or GDPR, is also required. Experience with internal and/or external QMS audits and managing or implementing internal business systems is preferred.

Responsibilities

The Quality & Regulatory Specialist will shape the future of oral care by collaborating closely with the Machine Learning and Operations teams to develop and implement QA/RA and security software modules. They will drive cybersecurity management alongside the Information Security Officer and support premarket regulatory submissions for FDA clearances and CE Mark. The specialist will also oversee the Quality Management System (QMS) to deliver impactful AI models and may support institutional review board (IRB) and clinical investigation study oversight. This role involves building strong relationships across teams and contributing to operational excellence within the organization.

Skills

QMS

SaMD

FDA submissions

CE Mark

Cybersecurity

IRB

Regulatory Affairs

Quality Assurance

Clinical Investigations

VideaHealth

AI solutions for dental diagnostic accuracy

About VideaHealth

VideaHealth focuses on improving dental care using artificial intelligence (AI) technology. The company provides tools that help dental service organizations (DSOs) and individual clinicians enhance their diagnostic accuracy and transparency in patient care. Their AI solutions integrate into existing dental practices, allowing professionals to make more precise diagnoses, which can lead to better treatment outcomes and increased patient satisfaction. VideaHealth differentiates itself by offering a subscription or licensing model for its services, ensuring a steady revenue stream while also providing demos to showcase their technology. The main goal of VideaHealth is to transform dental care by enhancing diagnostic capabilities and building trust between patients and their dental providers.

Boston, MassachusettsHeadquarters

2018Year Founded

$25.8MTotal Funding

SERIES_ACompany Stage

AI & Machine Learning, HealthcareIndustries

51-200Employees

Benefits

Fast paced and collaborative work culture in which you can gain experience, grow your technical skills and work on a wide variety of challenges over your time with us

A team led by a VP of Engineering who spent the first half of his career as an engineer who understands what engineers need to thrive and whose mission is for Videa to be the best team you'll ever join.

Competitive pay and equity.

Agile organization where being senior translates to being a mentor and role model for others. We lead by example.

Technical challenges on the leading edge of innovation where software and machine learning

Risks

Emerging dental AI startups threaten VideaHealth's market share.

Regulatory challenges may arise with new AI algorithm introductions.

Dependence on DSOs poses risks if they switch to competitors.

Differentiation

VideaHealth offers the only FDA-cleared dental AI pediatric algorithm on the market.

The company collaborates with DSOs to enhance diagnostic accuracy and transparency.

VideaHealth integrates AI solutions seamlessly into existing dental practices.

Upsides

Partnerships with DSOs like Heartland Dental expand VideaHealth's market reach.

The rise of personalized dental care aligns with VideaHealth's AI tool development.

Increasing 3D dental imaging adoption offers expansion opportunities for VideaHealth's AI capabilities.

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