OverviewQuality Assurance Regulatory Affairs (QARA) Specialist – Dedalus.

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Remote in Italy.

Part of the Global Quality and Assurance Team to drive quality and regulatory excellence in healthcare technology.What you’ll achieveAs a QARA Specialist you will ensure compliance with Quality and Regulatory standards across the company, contributing to better care and safer health technologies.ResponsibilitiesParticipates in problem management teams to assure regulatory conformance by monitoring complaint creation, escalation and follow upGuide and advise managers regarding compliance issues and ensure that decisions are documented and the company is following the correct processesEnsure timely resolution of all complaints and escalated issuesProvide feedback on product problems and risk evaluation with QARA pre-market and coordinate actions with QARA ServicesCoordinate and conduct Post Market Surveillance activities,

ensuring compliant regulatory reporting for applicable agencies and reporting incidents and trends within regulated timelinesPlay a leading role in addressing critical product issues and evaluating escalated complaints and problems for risksIdentify areas of improvement through analysis of product issues, quality metrics, internal audits and customer complaintsReport 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 teamQualificationsFamiliar 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 standardsExposure to risk management processesKnowledge of software development methodologies and practicesStrong problem

Quality Assurance Regulatory Affairs

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