Quality and Regulatory Specialist
VideaHealth
full-time
Posted on:
Location: Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
JuniorMid-Level
Tech Stack
Cyber Security
About the role
- 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
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
- Ability to commute into Boston office 2 days a week (required by application form)
- Will you now or in the future require sponsorship to work in the US? (application asks)
- Preferred: Experience with AI/Software as a Medical Device (SaMD)
- Preferred: Familiarity with IEC 62304, ISO 14971, and GDPR/HIPAA
- Preferred: Prior experience supporting regulatory submissions (e.g., FDA 510(k), CE Marking)
- Preferred: Knowledge of cybersecurity and electronic protected health information (ePHI) processes, HITRUST, SOC2, HIPAA, and/or GDPR