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.

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:

• Experience in medical device Quality and Regulatory leadership roles
• Strong background in Class II 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
• Ability to influence and collaborate effectively with engineering and operations functions
• Strong communication skills with the ability to operate in a fast-paced, hands-on environment
• Comfortable working in a founder-led, growing organisation with evolving structure
• Ability to operate onsite across multiple manufacturing locations as required

Apply today to learn more or reach out directly to View email address on click.appcast.io