Quality Assurance (QA) & Regulatory Assurance (RA) Manager – Person Responsible for Regulatory Compliance (PRRC)

📍 Location: Remote🕒 Occupation: Part-time (Contract basis)⚙️ About the positionMaintenance of an eQMS compliant with ISO 13485, ISO 14971, IEC 62304 & IEC 82304Creating, reviewing and editing SOPs, Templates, Work Instructions, ...Contributing to Design Control and Risk Management activities for Class III implantable devices, Class IIa surgical instruments and Class IIa Medical Device SoftwarePlanning and coordination of appropriate team trainingParticipating in management review meetings, internal audits, audits by Notified Bodies, …Execution of quality management activities (i.e. change control, handling of audit findings, customer complaints and nonconformities, CAPA management, supplier qualification, KPIs monitoring, ...)Ensuring that clinical evaluation is executed in accordance with applicable regulationsPreparing and maintaining the technical files for FDA clearance and MDR complianceResponsible for regulatory compliance and regulatory reportingPerforming data analysis and trend reportingCommunication with notified bodies and authorities, and handling of their inquiries🛠️ Skills requiredBachelor’s or Master’s degree in engineering, life sciences, health sciences, or a related fieldAt least 2 years of experience in a QA/RA role in the medical device industry; experience with medical device software is a plusSolid knowledge of ISO 13485, ISO 14971 and related regulatory frameworksKnowledge of IEC 62304 and IEC 62366Experience with CE marking and/or FDA clearance of medical devicesExperience in design, manufacturing, or quality control of medical devicesFluent in English; knowledge of Greek is preferredStrong problem-solving, communication, organizational and team collaboration skillsSelf-motivated, adaptable, and excited about working in a dynamic startup environment