Position Overview: Ensure our AI solution meets all UK regulatory requirements and lead the certification process for medical device approval, while serving as Clinical Safety Officer to guarantee safe deployment of our health technologies. Key Responsibilities: Navigate UKCA, and NHS Digital Technology Assessment Criteria (DTAC) processes Develop and maintain our regulatory strategy and documentation Act as Clinical Safety Officer, fulfilling DCB0129 responsibilities and supporting compliance with NHS Digital standards for the safe deployment of health technologies Liaise with regulatory bodies including MHRA and NHS Digital Implement and guide product teams through achieving ISO 13485 quality management system compliance Develop and maintain Clinical Safety documentation including Clinical Risk Management Files, Hazard Logs, and Clinical Safety Case Reports in accordance with DCB0129 and DCB0160 standards Ensure GDPR compliance in data handling and processing Lead internal audits and prepare for external regulatory inspections Provide clinical safety governance and oversight throughout the product development lifecycle Requirements: 5 years' experience in regulatory affairs for medical devices or healthcare software Specific experience with AI/ML medical device regulations Demonstrated experience as a Clinical Safety Officer or equivalent role Thorough knowledge and practical experience implementing DCB0129 and DCB0160 standards Deep understanding of UK and EU medical device regulations, including post-Brexit regulatory landscape Experience with successful CE marking and UKCA applications Hands-on experience guiding products through ISO 13485 certification Knowledge of GDPR and healthcare data protection requirements Excellent documentation and process management skills Strong understanding of clinical risk management principles and safety engineering practices