What are the responsibilities and job description for the Quality & Regulatory Specialist position at VideaHealth?
About Us
VideaHealth is a cutting-edge AI-powered solution for dentistry, developed by a team of business operators, engineers, AI scientists, and clinicians spun out of MIT. Our vision is to be the first company to diagnose a billion people globally. Our product is already used by thousands of dental clinicians to improve the quality of care through faster diagnoses, lower operating costs, and improved patient understanding.
About This Position
The QA/RA Specialist will play a critical role in ensuring compliance with global medical device regulations and standards while supporting the safe and effective deployment of AI-powered dental solutions. You’ll work cross-functionally with product, engineering, and leadership teams to maintain and enhance our Quality Management System (QMS) and to contribute to regulatory submissions and continuous improvement initiatives.
This is a hybrid position in our Boston HQ.
Key Responsibilities
VideaHealth is committed to cultivating an equitable, inclusive, and supportive environment for all employees. We believe this environment creates a safe space for employees to share their experiences, brainstorm ideas, and grow their careers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Compensation Range: $70K - $115K
VideaHealth is a cutting-edge AI-powered solution for dentistry, developed by a team of business operators, engineers, AI scientists, and clinicians spun out of MIT. Our vision is to be the first company to diagnose a billion people globally. Our product is already used by thousands of dental clinicians to improve the quality of care through faster diagnoses, lower operating costs, and improved patient understanding.
About This Position
The QA/RA Specialist will play a critical role in ensuring compliance with global medical device regulations and standards while supporting the safe and effective deployment of AI-powered dental solutions. You’ll work cross-functionally with product, engineering, and leadership teams to maintain and enhance our Quality Management System (QMS) and to contribute to regulatory submissions and continuous improvement initiatives.
This is a hybrid position in our Boston HQ.
Key Responsibilities
- Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 11/820, EU MDR, and other relevant regulations.
- Prepare regulatory documentation and submissions (FDA, CE, and other markets).
- Collaborate with product, engineering, and clinical teams to ensure design controls, risk management, and documentation meet regulatory requirements.
- Conduct internal audits, support external audits, and ensure timely resolution of findings.
- Support post-market surveillance, complaint handling, and vigilance reporting.
- Deliver training on quality and regulatory processes across the organization.
- Track and communicate changes in global regulations that may impact company processes or product
- Bachelor’s degree in life sciences, engineering, or a related field.
- 2–5 years of experience in QA/RA in the medical device industry.
- Strong working knowledge of ISO 13485, FDA QSR, and EU MDR.
- Excellent organizational, communication, and documentation skills.
- Ability to manage multiple projects in a fast-paced environment.
- Experience with AI/Software as a Medical Device (SaMD).
- Familiarity with IEC 62304, ISO 14971, and GDPR/HIPAA.
- Prior experience supporting regulatory submissions (e.g., FDA 510(k), CE Marking).
- Knowledge of cybersecurity and electronic protected health information (ePHI) processes. This includes working knowledge of HITRUST, SOC2, HIPAA, and/or GDPR
- Help shape the future of dentistry by ensuring safe, compliant, and impactful AI medical devices.
- Work alongside a world-class team of engineers, clinicians, and business leaders committed to improving healthcare outcomes.
- Join a fast-growing, well-funded startup with strong backing and industry partnerships.
- Access mentorship and growth opportunities in a collaborative, inclusive environment.
- Competitive compensation, benefits, and career advancement potential
VideaHealth is committed to cultivating an equitable, inclusive, and supportive environment for all employees. We believe this environment creates a safe space for employees to share their experiences, brainstorm ideas, and grow their careers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Compensation Range: $70K - $115K
Salary : $70,000 - $115,000
