Director of RA/QA

Director of Quality Assurance and Regulatory AffairsWe are actively looking for a Director of Regulatory Affairs & Quality Assurance to represent RA and QA on cross-functional project teams. This person will be responsible for implementing the overall regulatory strategy, quality assurance program, quality management system (QMS), and ensuring compliance with regulations and guidelines for medical devices. You will develop and drive a work culture committed to compliance, quality, and customer focus.The Client:Our client is an exciting startup company in the diagnostics space. Their first product is a commercial-ready biopsy test that provides an accuracy rating of greater than 95% for a condition affecting upwards of 6M people in the US and 20M+ worldwide.Key Quality Assurance responsibilities will include:Ensure company efforts (e.g. Design Control) comply with regulations and external standards.As management representative, coordinate ISO and customer audits, and FDA/CLIA inspections.Direct Document Control functions and ensure all change orders are reviewed for QMS impact.Participate in document development as needed.Manage analysis and records for customer complaints, NCMR, deviations, and CAPA.Manage receiving inspections and outgoing quality functions.Manage verification and validation of software system requirements, traceability, and testability.Manage the company''s risk management process to ensure the appropriate risk assessment is performed and documented.Monitor and report Key Performance Indicators (KPI''s) related to company quality objectives and lead QSMR meetings.Key Regulatory Affairs responsibilities will include:In consultation with external counsel, set US regulatory strategy for multiple products.Manage regulatory submissions and maintenance activities.Serve as regulatory representative in activities with Health Authorities.Provide regulatory support relating to labeling, promotional material, product changes and documentation.Ensure compliance with regulations and laws and manage requirements resulting from new regulations.Required Qualifications & CompetenciesB.S./B.A. in a science or related life science field; advanced degree preferred.Minimum of 8 years'' experience in regulatory and quality in the diagnostic medical device industry.Strong knowledge of Quality Management Systems (QMS); particularly ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.Understanding of HIPAA compliance.Experience with regulatory submissions for 510(k) and CE Mark; other OUS submissions a plus

Created: 2025-11-15