Senior Director, Quality Assurance & Regulatory Affairs

Job Description

Job Description

Who are we and why should you join us?

ConcertAI is building the future of precision medicine. We use advanced artificial intelligence and real-world data to transform how healthcare and life sciences generate evidence, make decisions, and improve patient outcomes—starting in oncology and rapidly expanding across therapeutic areas. Our teams partner with the world's leading pharmaceutical companies, providers, and research organizations to solve some of healthcare's most complex challenges.

At the core of our innovation is Cara, our next-generation AI platform that unlocks powerful insights from complex clinical, imaging, and molecular data. Combined with our Precision Suite—which unifies real-world data, advanced analytics, and scalable evidence generation—these solutions are transforming how clinical development, regulatory, and commercialization decisions are made.

ConcertAI brings together a portfolio of purpose-built solutions, including TeraRecon, an industry leader in advanced imaging and AI-driven visualization, and CancerLinQ, the ASCO-originated oncology platform advancing care quality and large-scale discovery.

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.

Role Summary

TeraRecon is seeking a strategic and innovative Senior Director, Head of Regulatory Affairs & Quality Assurance (RAQA) to lead our global Regulatory Affairs and Quality organization supporting our AI-powered medical imaging and Software as a Medical Device (SaMD) portfolio.

Reporting to executive leadership, 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 is an experienced leader who partners 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, we expect leaders to leverage AI responsibly to improve productivity, automate routine work, strengthen decision-making, and accelerate regulatory and quality operations.

At TeraRecon, AI is foundational to how we innovate and operate. Leaders are expected to embrace an AI-first mindset by leveraging AI to improve efficiency, enhance quality, automate routine work, accelerate decision-making, and foster continuous innovation while ensuring responsible, ethical, and compliant use of AI technologies.

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.

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.

Learn More About ConcertAI

Our team at ConcertAI is dedicated to transforming healthcare decision-making through the application of RWE and AI to improve patient outcomes. We work in a fast-paced, dynamic, high-performing culture where diversity, collaboration, and innovation are valued. Join us on our quest to create a world free of disease. Learn more about ConcertAI at , or follow us on LinkedIn. Serving 1,300 clinical sites globally, TeraRecon - a ConcertAI company - is a Best in KLAS solution provider for AI-empowered radiology, oncology, cardiology, neurology, and vascular surgery. In the future, the combination with ConcertAI could bring a single, advanced AI-augmented diagnosis and interpretation capability from clinical trials to patient care.

EEO & ADA Statement

ConcertAI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. We are dedicated to providing reasonable accommodations throughout the application and hiring process, as well as during employment, in accordance with applicable federal, state, and local laws. Requests for accommodation will be handled confidentially and in accordance with applicable law.