Quality Assurance Regulatory Affairs (QARA) Specialist

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 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