Director of Quality Assurance & Regulatory Affairs

Currently supporting a growing, founder-led Medical Device company seeking a Director Quality Assurance! The business operates across multiple US sites and supports the development and manufacturing of high-quality Class II/lll medical devices within a fast-paced environment. With a strong portfolio of products and increasing customer demand, this is a key leadership hire responsible for strengthening quality systems, driving compliance excellence, and leading audits! This individual will take ownership of the overall Quality function, leading both strategic and hands-on operational quality activities across multiple manufacturing sites. The role will play a critical part in strengthening their QMS and act as the key point of leadership for FDA, customer and notified body interactions. Key Responsibilities: Lead the overall Quality and Regulatory function across multiple US manufacturing sites Own and drive QMS remediation, consolidation, and continuous improvement activities Act as primary lead for FDA inspections, notified body audits, and customer audits Oversee quality systems across design, manufacturing, and post-market surveillance Provide leadership and oversight of design quality engineering and QC functions Manage and develop a team of quality professionals (approx. 5 direct and indirect reports) Partner closely with engineering and operations to ensure quality is embedded across all processes Act as the key quality authority, balancing compliance requirements with operational delivery Support regulatory activities including device registrations, UDI, and FDA submissions as required Drive a culture of accountability, continuous improvement, and operational excellence Key Requirements: 8+ years experience in Quality Assurane Strong background in Class II/lll medical devices and ISO 13485 / 21 CFR 820 environments Proven experience leading FDA inspections and external audits Demonstrated experience in QMS implementation, remediation, or consolidation Background in contract manufacturing or multi-site manufacturing environments strongly preferred Experience managing cross-functional teams within QA/QC and design quality environments Strong leadership capability with proven ability to develop and mentor teams #J-18808-Ljbffr Barrington James