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.

Le seguenti informazioni hanno lo scopo di fornire ai potenziali candidati una migliore comprensione dei requisiti per questo ruolo.

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 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. xkiyazw 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

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