Quality Assurance Regulatory Affairs
Pubblicato il 16-10-2026 - Dedalus in Modena
Overview Quality Assurance Regulatory Affairs (QARA) Specialist – Dedalus. Remote in Italy. Part of the Global Quality and Assurance Team to drive quality and regulatory excellence in healthcare technology. What you’ll achieve As a QARA Specialist you will ensure compliance with Quality and Regulatory standards across the company, contributing to better care and safer health technologies. Responsibilities * Participates in problem management teams to assure regulatory conformance by monitoring complaint creation, escalation and follow up * Guide and advise managers regarding compliance issues and ensure that decisions are documented and the company is following the correct processes * Ensure timely resolution of all complaints and escalated issues * Provide feedback on product problems and risk evaluation with QARA pre-market and coordinate actions with QARA Services * Coordinate and conduct Post Market Surveillance activities,
ensuring compliant regulatory reporting for applicable agencies and reporting incidents and trends within regulated timelines * Play a leading role in addressing critical product issues and evaluating escalated complaints and problems for risks * Identify areas of improvement through analysis of product issues, quality metrics, internal audits and customer complaints * Report on Post Market activities during Management Review meetings (site, divisional and healthcare levels) * Provide senior-level contributions to develop the QARA department into a professional, proactive and competent team Qualifications * Familiar with international regulations and standards pertaining to medical devices development and deployment; familiarity with ISO 9001, ISO 13485, ISO 14971 and ability to interpret and work with regulations and standards * Exposure to risk management processes * Knowledge of software development methodologies and practices * Strong problem solving and project management skills * Excellent communication (verbal and written), research, o