Quality Assurance & Regulatory Affairs Specialist
Manchester, North West, United Kingdom
Hybrid / WFH Options
Hybrid / WFH Options
Genedrive
Join Genedrive as a Senior Quality Assurance & Regulatory Affairs Specialist! Shape the future of global medical diagnostics while driving compliance excellence in a dynamic and innovative environment. QA/RA Specialist Manchester, M13 9XX Full-time, 12-month contract (Maternity Cover) £35,000 - £45,000 per annum Please Note: Applicants must be authorised to work … in point-of-care testing on a global scale. The Role Genedrive is seeking a knowledgeable and driven Senior Quality Assurance & Regulatory Affairs Specialist to join their QA/RA team on a 12-month maternity cover contract. Key Responsibilities: Lead and support continuous improvements within the Quality Management System (QMS) Collaborate with all departments and external … stakeholders to maintain regulatory compliance Provide QA/RA expertise throughout product development and change control processes Guide risk management and post-market surveillance activities Conduct root cause analyses for CAPA investigations Review SOPs, software development documents, and regulatory submissions Deliver training to ensure quality and regulatory understanding across the business Perform internal and supplier audits and support external More ❯
Employment Type: Contract, Work From Home
Rate: £40,000
Posted: