Quality Assurance Regulatory Affairs (QARA) Specialist

h3Overview /h3pQuality 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. /ph3What you’ll achieve /h3pAs a QARA Specialist you will ensure compliance with Quality and Regulatory standards across the company, contributing to better care and safer health technologies. /ph3Responsibilities /h3ulliParticipates in problem management teams to assure regulatory conformance by monitoring complaint creation, escalation and follow up /liliGuide and advise managers regarding compliance issues and ensure that decisions are documented and the company is following the correct processes /liliEnsure timely resolution of all complaints and escalated issues /liliProvide feedback on product problems and risk evaluation with QARA pre-market and coordinate actions with QARA Services /liliCoordinate and conduct Post Market Surveillance activities, ensuring compliant regulatory reporting for applicable agencies and reporting incidents and trends within regulated timelines /liliPlay a leading role in addressing critical product issues and evaluating escalated complaints and problems for risks /liliIdentify areas of improvement through analysis of product issues, quality metrics, internal audits and customer complaints /liliReport on Post Market activities during Management Review meetings (site, divisional and healthcare levels) /liliProvide senior-level contributions to develop the QARA department into a professional, proactive and competent team /li /ulh3Qualifications /h3ulliFamiliar 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 /liliExposure to risk management processes /liliKnowledge of software development methodologies and practices /liliStrong problem solving and project management skills /liliExcellent communication (verbal and written), research, organizational and interpersonal skills /liliDatabase and software tool manipulation skills /liliKnowledge of statistical techniques and data analysis /liliVery good English skills both verbal and written /liliUniversity degree in Engineering, Computer Science or Science /li /ulpDedalus is a leading healthcare technology company dedicated to helping clinicians and nurses deliver better care. We are committed to diversity and inclusion and to creating a respectful, inclusive culture across our global workforce. /ppLocation: Italy (remote) /ppEmployment type: Full-time /p #J-18808-Ljbffr