Proactive Global
Surrey, UK
QARA Administrator Salary 28k- 30k per annum Details Job Summary: The QARA Administrator supports the Quality Assurance (QA) and Regulatory Affairs (RA) functions to ensure the Planer's medical devices comply with applicable regulatory requirements (e.g., ISO 13485, MDR 2017/745, FDA 21 CFR 820). This role plays a key part in maintaining documentation, coordinating quality system activities, supporting regulatory submissions, and ensuring ongoing compliance across the business. Key Responsibilities: Quality Assurance: Maintain and update the Quality Management System (QMS) in accordance with ISO 13485 and internal procedures. Administer document control processes, ensuring timely revision, approval, and distribution of controlled documents. Support CAPA, non-conformity (NC), complaint handling, and change control processes. Assist with internal and external audits (Notified Bodies, FDA, suppliers). Ensure training records are accurate, complete, and...
