Quality & Regulatory Specialist
VideaHealthBoston, Massachusetts, United States
Posted October 21, 2025
Full Time
About the Company
VideaHealth is an AI-driven dental assistant platform developed at Harvard and MIT, offering enterprise solutions that enhance patient trust, increase productivity, and deliver measurable business value. With the largest and most diverse dataset in the market, VideaHealth partners with leading DSOs and is backed by prominent venture capital firms including Spark Capital, Zetta Venture Partners, and Pillar VC.
Job Description
VideaHealth is seeking a Quality & Regulatory Specialist to ensure compliance with global medical device regulations. This role involves maintaining and improving the Quality Management System, preparing regulatory documentation, and supporting regulatory submissions. The position will work cross-functionally with product, engineering, and leadership teams.
Requirements
- Maintain and improve the Quality Management System 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.
Benefits
- Competitive compensation
- Career advancement opportunities
- Mentorship and growth opportunities
- Access to industry partnerships
- Well-funded startup
