Director of Quality & Regulatory

Director of Quality & Regulatory

Medical Device

Currently supporting a growing, founder-led medical device manufacturing organisation seeking a senior Quality & Regulatory leader to join at a pivotal stage of expansion and operational transformation. The business operates across multiple US sites and supports the development and manufacture of high-quality Class II medical devices within a fast-paced, contract manufacturing environment. With a strong pipeline of products and increasing customer demand, this is a key leadership hire responsible for strengthening quality systems, driving compliance excellence, and embedding structure across a scaling organisation

.
This individual will take ownership of the overall Quality and Regulatory function, leading both strategic and hands-on operational quality activities across multiple manufacturing sites. The role will play a critical part in QMS remediation and consolidation following a legacy dual-system environment and will act as the key point of leadership for FDA, customer, and notified body interactions. The successful candidate will also partner closely with operations and engineering teams to ensure quality is embedded across design, manufacturing, and post-market activities, while leading and developing a growing quality tea

m.
Key Responsibiliti

• es:Lead the overall Quality and Regulatory function across multiple US manufacturing si
• tesOwn and drive QMS remediation, consolidation, and continuous improvement activit
• iesAct as primary lead for FDA inspections, notified body audits, and customer aud
• itsOversee quality systems across design, manufacturing, and post-market surveilla
• nceProvide leadership and oversight of design quality engineering and QC functi
• onsManage and develop a team of quality professionals (approx. 5 direct and indirect repor
• ts)Partner closely with engineering and operations to ensure quality is embedded across all proces
• sesAct as the key quality authority, balancing compliance requirements with operational deliv
• erySupport regulatory activities including device registrations, UDI, and FDA submissions as requi
• redDrive a culture of accountability, continuous improvement, and operational excelle

nce
Key Requireme

• nts:Experience in medical device Quality and Regulatory leadership r
• olesStrong background in Class II medical devices and ISO 13485 / 21 CFR 820 environm
• entsProven experience leading FDA inspections and external au
• ditsDemonstrated experience in QMS implementation, remediation, or consolida
• tionBackground in contract manufacturing or multi-site manufacturing environments strongly prefe
• rredExperience managing cross-functional teams within QA/QC and design quality environm
• entsStrong leadership capability with proven ability to develop and mentor t
• eamsAbility to influence and collaborate effectively with engineering and operations funct
• ionsStrong communication skills with the ability to operate in a fast-paced, hands-on environ
• mentComfortable working in a founder-led, growing organisation with evolving struc
• tureAbility to operate onsite across multiple manufacturing locations as requ

ired
Apply today to learn more or reach out directly with your CV to rbanton@barringtonjame