Quality Assurance Regulatory Affairs
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* 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 interpersonal skills
* Database and software tool manipulation skills
* Knowledge of statistical techniques and data analysis
* Very good English skills both verbal and written
* University degree in Engineering, Computer Science or Science Dedalus 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.
Location:
Italy (remote) Employment type: Full-time #J-18808-Ljbffr
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