Quality Assurance and Regulatory Engineer Homebased Opportunity: Do you have experience in quality assurance and regulatory affairs for medical devices? Do you have experience of working to ISO 13485, ISO 14971 and UK MDR, Regulation (EU) 2017/745, MDSAP, ISO 9001 standards? Want to work for an innovative medical device manufacturing company? If yes then this is the role for you. Your role as a Quality Assurance and Regulatory Engineer will involve: Supplier and Purchasing: Reviewing the supplier onboarding, supplier revaluation and purchasing processes to ensure compliance with specific country regulations. Creating new documents to support the supplier and purchasing processes. Establishing controls for critical suppliers. Creating supplier quality agreements. Labelling Reviewing product and software labelling and conducting a gap analysis to ensure labels meet all regulatory and compliance standards. Risk Management Supporting product risk management activities according to current procedures. Reviewing all processes within the quality management system and document process risks in accordance with ISO 14971. Trend Analysis Establishing a process to collect, analyse and report on quality data to identify trends and areas for improvement. Training Creating training material on relevant regulations, standards, and guidance (e.g. UK MDR, Regulation (EU) 2017/745, MDSAP, ISO9001). Regulatory: Supporting the QARA team in: Creating a documentation pack aligned to ..... full job details .....