Quality Assurance

Dedalus Group is the leading healthcare and diagnostic software provider in Europe and one of the largest in the world. The shareholding structure ensures stability and great financial capacity through the presence of Ardian, the largest private investment company in Europe and 4th in the world. Starting in 2016, Dedalus has decided to accelerate its expansion strategy by targeting a growing demand for innovative and comprehensive ICT and Clinical transformation solutions.

With the acquisition of Agfa Healthcare IT, Dedalus consolidates its leadership as pan-European player in healthcare software industry, with a market leading position in Hospital IT (HCIS) and Diagnostic (DIS) in Germany, Italy and France, with a strong footprint in Austria, Switzerland, Spain, Belgium, China, Brazil and several locations in the Latin America, Middle East and Africa, reaching over 30 different countries.

Today Dedalus employs over 3,400 highly skilled resources; it has the largest R&D software team in the sector in Europe with more than 1,100 people.
Thanks to its undisputed cutting-edge portfolio of leading the new generation solutions, Dedalus covers the whole spectrum of needs for healthcare operators, supporting over 5000 hospitals and 4800 laboratories around the world.

The Healthcare ecosystems deliver mission critical services and tasks in an highly complex and fast changing environment. A radical change of the healthcare service delivery paradigm is happening: shifting from the “episode centric” approach to the “continuum of care” approach, with the person’s needs at the very center of the solution design process.
With its innovative framework of comprehensive and process-oriented suite of solutions, Dedalus Group aims to enable such a revolutionary transformation for all healthcare organizations, for Caregivers and Professionals and for the Patients and Citizens.

Our mission is to enable and enhance clinical cooperation and processes optimization with a incrementally deploy approach to protect our customers’ past investments. Each person, as a complex individual with several and evolving needs, is the end point and the starting point of the Group’s activities and the ultimate beneficiary. For this reason, we are so proud of doing a «very special job» each day.

**Position:**:The Resource will be responsible for:

- Monitoring the process adherence for the Pre-Market Procedures in their area;
- Supervising the completeness of design history files and regulatory submissions;
- Ensuring the regulatory and process conformance for development and maintenance projects as a member of cross-functional teams
- Creation and maintenance of key regulatory deliverables of the projects;
- Ensuring the adherence to the medical device risk analysis process as risk moderator of the development team;
- Facilitating the regulatory compliance in design control processes to ensure that there are no compliance issues during regulatory inspections;
- Performing internal audits and defending Dedalus premarket activities during external regulatory inspections and audits;
- Being a QARA ambassador on product teams.

**Requirements:

- University Degree in Biomedic Engineering, Computer science, LifeScience, Biostatisctics or equivalent;
- At least 2 years of experience gained in the healthcare and/or medical devices sector
- Knowledge of design control regulations and requirements;
- Knowledge of medical device regulatory submission regulations and requirements;
- Awareness of CAPA/NCR regulations and requirements;
- Knowledge of privacy and security regulations and requirements (GDPR);
- Subject matter expert in regulatory affairs preferably with knowledge of relevant health care quality standards and requirements;
- Italian mothertongue or fluent;
- Good level of English (B2/C1)

**Other information:**:Other skills required should be:

- Good organizational skills and attention to details;
- Able to maintain strict confidentiality of sensitive data, records, files, conversations;
- Self-motivated and able to grasp new concepts and learn quickly;
- Ability to manage projects and deliverables with a high level of accuracy and completeness;
- Ability to solve problems while exercising sound judgment and timely decision-making skills;
- Verbal and written communication skills: must be able to communicate technical information to development teams in a supportive and meaningful manner;
- Comfortable with working with Business partners to investigate complaints.