Head of Quality & Regulatory Compliance (Director Level)

AG Mednet
Boston, MA
Job Description
Role Overview

AG Mednet is a software platform company seeking a Head of Quality & Regulatory Compliance to provide strategic leadership and oversight of quality and regulatory programs. The role is responsible for owning and scaling AG Mednet's Quality Management System (QMS) and regulatory compliance strategy across cloud-based SaaS products and services.

What You Will Do

Serve as a player-coach, combining hands-on ownership of quality, compliance, and regulatory activities with leadership and mentorship of the QRC team. Monitor regulatory and compliance developments, maintain embedded quality and compliance oversight, and develop sustainable systems and processes.

Why It Might Be a Fit

The ideal candidate brings deep experience supporting regulated B2B SaaS platform development and delivery, with a strong ability to influence cross-functional stakeholders and communicate complex regulatory topics clearly.

Requirements

  • Bachelor's degree in a relevant field (Regulatory Affairs, Life Sciences, Computer Science, or similar)
  • 7-10+ years of relevant experience in quality, regulatory compliance, and/or risk management roles
  • Profound knowledge of regulations and controls (e.g., 21 CFR Part 11, CSV, ICH GCP, HIPAA, GDPR, SOC 2)
  • Strong project management experience with a track record of successfully leading and completing quality and compliance improvement projects

Benefits

  • Salary Range: 150,000 - 180,000
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