Senior Director, Quality Assurance & Regulatory Affairs

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 Tera Recon, an industry leader in advanced imaging and AI-driven visualization, and Cancer

LinQ, 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.

Tera Recon 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 Tera Recon, 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.

• Lead Tera Recon’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 withFDA 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…