Senior Director, Quality Assurance & Regulatory Affairs

ConcertAI•New York, NY

About The Position

ConcertAI is building the future of precision medicine using advanced artificial intelligence and real-world data to transform healthcare and life sciences. Our teams partner with leading organizations to solve complex healthcare challenges. The core of our innovation is Cara, an AI platform, combined with our Precision Suite, which unifies real-world data, advanced analytics, and scalable evidence generation. ConcertAI also includes TeraRecon, a leader in advanced imaging and AI-driven visualization, and CancerLinQ, an oncology platform. Joining ConcertAI means working with bold thinkers and healthcare experts on innovative, high-impact products that improve patient lives in a fast-growing, mission-driven organization at the forefront of AI-enabled healthcare. TeraRecon is seeking a strategic and innovative Senior Director, Head of Regulatory Affairs & Quality Assurance (RAQA) to lead its global Regulatory Affairs and Quality organization supporting its AI-powered medical imaging and Software as a Medical Device (SaMD) portfolio. This role is responsible for driving global regulatory strategy, maintaining an effective Quality Management System (QMS), ensuring worldwide compliance, and enabling rapid product innovation. The ideal candidate will partner across Engineering, Product, Clinical, Security, and Commercial teams to accelerate product development while maintaining the highest standards of quality, compliance, and patient safety. As an AI-first organization, leaders are expected to leverage AI responsibly to improve productivity, automate routine work, strengthen decision-making, and accelerate regulatory and quality operations.

Requirements

Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related scientific discipline; advanced degree preferred.
12+ years of progressive Regulatory Affairs and/or Quality Assurance experience within the medical device or Software as a Medical Device (SaMD) industry, including 7+ years in leadership roles.
Deep knowledge of FDA QMSR, ISO 13485, EU MDR, MDSAP, IEC 62304, ISO 14971, and global medical device regulations.
Demonstrated success leading FDA inspections, Notified Body audits, and global regulatory submissions.
Experience supporting AI-enabled medical devices, cloud software, cybersecurity, or digital health solutions is strongly preferred.
Exceptional leadership, communication, and cross-functional collaboration skills with the ability to influence executive stakeholders.
Travel: Approximately 20–30%, including international travel as needed.

Responsibilities

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.
Partner with Product Management and Engineering to integrate regulatory and quality requirements throughout the software development lifecycle and accelerate product releases.
Monitor evolving global regulations related to AI, Software as a Medical Device (SaMD), cybersecurity, and digital health technologies.
Act as the Person Responsible for Regulatory Compliance (PRRC) or ensure organizational compliance with applicable EU MDR requirements.
Drive operational excellence through data-driven quality metrics, risk management, and AI-enabled process improvements.