Quality & Regulatory Associate

Quality & Regulatory Associate Location – Manchester Sector – Medical Devices Salary - £35,000-£45,000 (dependent on experience) Duration – Permanent, full-time. Hybrid options if needed but expectation is a min of 3-days on site per week. The opportunity: Our client is an exciting Med-tech business based in Manchester and are currently seeking a skilled Quality professional to join their team to support with the optimisation of the Quality Management System (QMS) and Regulatory processes as the approach ISO13485 readiness and FDA preparation. The responsibilities: As the Quality & Regulatory Associate your primary function is supporting with QA/RA documentation, design controls, Quality processes and implementation. You will need to liaise closely with internal teams and offer a pragmatic approach to managing quality and regulatory requirements within the business: Key functions include: * Support day-to-day operation of ISO13485 QMS * Support with FDA 510(k) technical documentation * Maintain Design File History and Technical documentation * Maintain and review quality documentation, change controls and CAPA processes * Prepare documentation for internal readiness reviews and audits * Support and promote continuous improvement in quality processes The ideal applicant: This role is seeking an individual with a delivery-focused mindset and a pragmatic approa...