VideaHealth

Quality and Regulatory Specialist

VideaHealth

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Job 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