Regulatory Affairs and Quality Assurance About Us Fortress Diagnostics Ltd is a leading provider of diagnostic solutions, committed to delivering high-quality, compliant products to global markets. We are seeking a detail-oriented RA/QA assistant to support regulatory compliance and maintain our quality management systems Role Overview The RA/QA Assistant supports the Regulatory Affairs and Quality Assurance functions by maintaining documentation, assisting with compliance activities, and ensuring the Quality Management System (QMS) is effectively implemented. This is an ideal role for someone looking to build a career in regulatory and quality within the medical devices or diagnostics sector. Key Responsibilities Regulatory Affairs Support Assist in preparing regulatory documentation and submissions (e.g., UKCA, CE marking) Liaise with regulatory authorities and notified bodies Maintain regulatory files and technical documentation Support product registrations in international markets Track regulatory changes and assist in updating internal processes Quality Assurance Support Maintain document control systems (SOPs, forms, records) Support the QMS in line with ISO 13485 and company procedures Assist with CAPA, non-conformances, and deviation records Help prepare for internal and external audits Support complaint handling and investigations Administrative & Cross-Functional Support Maintain accurate records and databases Coordinate with internal departments to ensure compliance Assist with training records and quality documentation updates Assist in risk management and validation activities Requirements Degree or diploma in life sciences, biomedical science, or related field Basic knowledge of ISO 13485 or quality systems Experience in RA/QA within medical devices, diagnostics, or healthcare Familiarity with IVDR requirements (preferred) Strong organisational skills and attention to detail Good written and verbal communication skills Ability to manage multiple tasks and meet deadlines Desirable Internship or previous experience in a regulated environment Familiarity with technical documentation and risk management Interest in regulatory affairs and quality assurance