Position: Director of Quality Assurance & Regulatory Affairs Location: Middlesex Salary: £85K + benefits Purpose of the Role To lead global quality and regulatory strategy, ensuring compliance across the company's product portfolio. This role is pivotal in enabling market access, maintaining high standards, and embedding quality throughout the product lifecycle. Strategic Leadership Represent role model or servant leader model leadership as a member of senior site management team. Develop and implement the QARA strategy aligned with business goals and regulatory compliance requirements. Collaborate with Engineering, Operations, and Commercial teams to integrate quality and compliance from concept to delivery. Represent the company in regulatory compliance audits and external engagements.Regulatory Affairs Oversee global product registrations and submissions, including CE marking and international approvals for company products Support in defining regulatory pathways early in product development, including Intended Use and Risk Classification. Ensure compliance with ISO 13485, MDR, FDA 21 CFR Part 820, and other relevant standards.Quality Assurance Maintain and enhance the Quality Management System (QMS). Lead internal and supplier audits, investigations, and corrective actions. Analyse QA data to drive continuous improvement and risk mitigation.Project Oversight Lead QARA team in managing regulatory docum...