# Senior Director, Quality Assurance & Regulatory Affairs at ConcertAI

- Company: ConcertAI
- What the company does: ConcertAI orchestrates clinical expertise, real-world data, and applied AI to deliver practical intelligence for the demands of oncology and other complex diseases.
- Company website: https://www.concertai.com
- Type: Startups
- Level: Principal and up
- Location: United States
- Work setup: On-site
- Posted: 2026-08-25
- Apply by: 2026-10-09
- Apply: https://job-boards.greenhouse.io/concertai/jobs/4306362009
- Page: https://www.1752.vc/careers/jobs/concertai-senior-director-quality-assurance-and-regulatory-affairs/

## About the role

Joining ConcertAI means working alongside bold thinkers, builders, and healthcare experts on innovative, high-impact products that directly improve patient lives. You’ll be part of a fast-growing, mission-driven organization at the forefront of AI-enabled healthcare, with meaningful opportunities for growth and leadership.

## What they're looking for

- Lead TeraRecon's global Regulatory Affairs and Quality Assurance organization, providing strategic direction and developing high-performing teams
- Own and continuously improve the Quality Management System (QMS), ensuring compliance with FDA QMSR , ISO 13485 , EU MDR , MDSAP , and other applicable global regulations
- Develop and execute global regulatory strategies supporting new product development, AI-enabled software, and international market expansion
- Oversee regulatory submissions , including FDA 510(k) s, CE Mark documentation , international product registrations , and technical files
- Serve as the primary company representative during FDA inspections, Notified Body audits, and other regulatory agency interactions
- Lead Management Reviews, CAPA , internal audits , complaint handling , document control, supplier quality, post-market surveillance , and continuous improvement initiatives

Tags: HC QARA