Quality & Regulatory Specialist

VideaHealth • Boston, MA

2d • Hybrid

About The 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.

Requirements

• 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.

Nice To Haves

• 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

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 51-100 employees