Head of Quality Assurance and Regulatory Affairs

About One BiosciencesOne Biosciences (OBS) is a precision oncology company leveraging single-cell multiomics and AI analytics to decode tumor biology at unprecedented resolution. Our flagship clinical service, OneMap, transforms FFPE tumor biopsies into actionable clinical insights within two weeks, bridging translational research and precision medicine.OBS operates as a dual-market clinical testing organization, with labs in Europe and North America. We are currently establishing an ISO 13485 compliant European QMS under the IVDR framework, a New York State CLEP approved LDT laboratory, and a harmonized global quality system enabling CE-marking, CLIA/CLEP licensing, and future FDA submissions.Role SummaryThe Head of QARA will build, lead, and oversee the global Quality & Regulatory Affairs strategy and systems across OBS. This leader will ensure our operations, software, and laboratories meet all applicable regulatory, quality, and data-integrity standards under both EU IVDR and US CLIA/CLEP/FDA frameworks.You will define and implement the integrated quality system spanning Europe and the US, drive ISO 13485 certification, oversee IVDR Technical Documentation (TD) preparation, and manage regulatory submissions for both markets.Key ResponsibilitiesQuality Management System (QMS) Leadership- Establish, maintain, and continuously improve the ISO 13485-compliant QMS for OBS’ European operations.- Oversee alignment of the US QMS to CLIA, CAP, and NY State (CLEP) requirements while maintaining global harmonization.- Serve as the Management Representative under ISO 13485 and the Quality Director for CLEP/CLIA.- Manage document control, training, CAPA, internal audits, risk management, and supplier qualification.Regulatory Affairs (EU & US)- Develop and execute the regulatory strategy for CE-marking of OBS’ IVD software and diagnostic assays under EU IVDR (Class C).- Own relationships with Notified Bodies (NB) and regulatory authorities in Europe and the US.- Oversee preparation and submission of Technical Documentation (TD) and Performance Evaluation Reports (PER).- Lead CLIA and NY State (CLEP) applications and ongoing renewals.- Coordinate FDA interactions for future SaMD submissions.Cross-Functional Quality Integration- Collaborate with R&D, Bioinformatics, and Clinical teams to integrate design controls, software verification/validation (V&V), and data integrity within the QMS.- Partner with the COO and Lab Directors to ensure process alignment across manufacturing, software, and clinical testing operations.- Lead management reviews, internal audits, and preparation for external audits (Notified Body, NY State, CAP, CLIA).Leadership & Team Development- Build and mentor a small but high-impact QARA team in Paris and the US.- Define global SOP frameworks and training programs.- Act as the primary interface between executive leadership and regulatory bodies.Education & Experience- Advanced degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or Quality Management.- 10+ years in Quality and Regulatory leadership roles within IVD, Medical Device, or Molecular Diagnostics companies.- Proven experience achieving ISO 13485 certification and CE-marking under IVDR.- Direct experience with CLIA, CAP, and NY State (CLEP) laboratory regulations.- Familiarity with IEC 62304 (Software Lifecycle), ISO 14971 (Risk Management), and GDPR/HIPAA compliance frameworks.Skills & Attributes- Strategic mindset with strong operational discipline and regulatory rigor.- Excellent understanding of European IVDR and US laboratory/IVD regulatory frameworks.- Strong leadership, communication, and stakeholder-management skills.- Fluent in English; French proficiency preferred.