QA and RA Specialist

Job DescriptionQA RA Specialist Merseyside Diagnostics About the Company:We are looking for an experienced QA and RA professional with a knowledge of IVDR to join the compliance team at an established and expanding diagnostics company. Responsibilities:Ensure company-wide compliance with all applicable IVD medical device regulations, international standards (e.g., ISO 13485), and statutory requirements (including Health & Safety and Environmental regulations).Oversee the regulatory compliance of product design, manufacture, marketing, distribution, and post-market activities across all global markets.Manage and coordinate product registrations in line with country-specific regulatory requirements, ensuring timely market access.Maintain a controlled, up-to-date repository of applicable regulations, directives, and standards, ensuring availability and visibility for all relevant teams.Lead regulatory training initiatives to ensure all employees understand and comply with applicable standards relevant to their roles.Support and help maintain the companys Quality Management System, assisting the QA Manager in driving continual improvement and regulatory alignment.Lead customer complaint investigations, working cross-functionally with internal teams to conduct root cause analysis and implement corrective and preventive actions.Support post-market surveillance and vigilance activities, including preparation and management of Field Safety Notices (FSNs), Customer Advisory Notices, and communication with Competent Authorities.Act as a regulatory advisor to the International Sales team, providing guidance on in-country regulatory requirements and resource implications for market entry.Serve as a delegated Person Responsible for Regulatory Compliance (PRRC) for final sign-off of Quality Control documentation, in accordance with EU IVDR 2017/746.Oversee compliance with Animal By-Product (ABP) regulations, ensuring full documentation and traceability for relevant raw materials.Ensure effective implementation and continuous management of all Quality Management System processes and controls in line with regulatory and ISO requirements.Partner with R&D and Quality Control teams to ensure product technical documentation is complete, accessible, and audit-ready.Provide proactive regulatory and quality assurance support to all business functions, fostering a culture of compliance and continuous improvement.Manage and monitor the internal audit schedule, ensuring timely completion and resolution of audit findings.Support global regulatory submissions, queries, and audits, preparing high-quality written reports and responses as required.Requirements:Degree in Life Sciences.Experience in the diagnostics industry.Experience with IVDR and the transition from IVDD.Experience investigating and dealing with complaints.Strong communication skills.Good knowledge of medical device regulations.

Created: 2025-07-03