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, organizational and interperso

Quality Assurance Regulatory Affairs

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