Job Title: Quality Assurance and Regulatory Affairs Lead Salary: £60,000 - £65,000 Location: London, UK Job Type: Permanent A London based Start-up Medical Device company developing a Class 1 Measuring Device is on the look out for a Quality and Regulatory Lead to join their growing business. They are looking for an individual that is hard working and self motivated to assist with all things QARA. Key Responsibilities: Developing and executing regulatory strategies for FDA clearance, followed by other markets. Installing and marinating an appropriate QMS (including risk management processes). This is likely to be compliant with ISO 13485 and CFR21 Part 820. Oversee internal audits and manage external inspections by notified bodies and regulatory authorities. Manage regulatory documentation, including submission dossiers, technical files, and risk management files (ISO 14971). Provide guidance on Verification and Validation activities, ensuring alignment with FDA and international standards (e.g., ISO 60601, ISO 10993). Ensure product labeling, packaging, and instructions for use (IFU) meet regulatory requirements for the US and other markets. Experiences and Qualifications Required: Proven experience in QARA including preparing and submitting regulatory submissions and installing and managing a QMS. Familiarity with global medical device regulations, including CFR 21, EU MDR and UKCA, and associated market requirements. Experience with common international standards for electronic medical devices (ISO 13485, 14971, 10933, 60601). Experience with external audit of quality and risk management systems. Interviews: Starting in January How to apply: Apply to e.smailesx4lifesciences to learn more about the role or connect with me on LinkedIn to hear about regular job updates available with X4 Life Sciences.