ConcertAI orchestrates clinical expertise, real-world data, and applied AI to deliver practical intelligence for the demands of oncology and other complex diseases.
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
More about this role
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...
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