Quality Assurance Regulatory Affairs (QARA) Specialist

Dedalus; Bologna; Remote; EUR 40,000 - 65,000; Full time

Job summary

A leading healthcare technology company is looking for a Quality Assurance Regulatory Affairs Specialist to ensure compliance with Quality and Regulatory standards. The role involves monitoring complaint handling, guiding managers on compliance, and conducting Post Market Surveillance activities. Strong problem-solving and communication skills are necessary. The position is remote in Italy and full-time.

Qualifications

• Familiar with international regulations and standards for medical devices.
• Knowledge of software development methodologies.
• Very good English skills in verbal and written communication.

Responsibilities

• Ensure compliance with Quality and Regulatory standards.
• Monitor complaint creation and follow up.
• Conduct Post Market Surveillance activities.
• Guide and advise managers on compliance issues.

Skills

Problem solving

Project management

Excellent communication

Risk management

Statistical techniques

Database manipulation

Education

University degree in Engineering, Computer Science or Science

Job description

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