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 & 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...