Quality Assurance & Regulatory Affairs Post Market Specialist

Beschreibung

About Dedalus

We are a Global European Health Software Company and one of the largest in the world’s largest. Our shareholding structure guarantees financial capacity and stability, thanks to the investment from Ardian, the largest private investment company in Europe and the fourth largest in the world. In 2016, Dedalus decided to accelerate its expansion strategy by focusing on the accelerating demand for innovative and comprehensive solutions to support the digital transformation of the healthcare ecosystem Working across the whole continuum of care and offering Open Standards-based solutions, Dedalushelps the healthcare organisations to deliver new models of care. The benefit of our approach is enabling the delivery of better healthcare outcomes. We have over 50 years’ experience of delivering healthcare software and services to healthcare customers. Our software is used widely across the world, managing more than 3 billion diagnostic results, 333 million Patient Records, 28 million Inpatient and 32 million Emergency admission, and in primary care, we serve more than 79 million Citizens.

Dedalus at a glance

Today, Dedalus employs more than 6.200 highly skilled qualified people; it has the largest software R&D team in the industry in Europe with more than 2.100 staff. Thanks to our portfolio of leading next-generation solutions, Dedalus covers the entire spectrum of healthcare professionals’ needs, and today we support over 6.300 hospitals and 5.300 laboratories worldwide. At Dedalus, we understand the importance of collaboration in the new models of care delivery. These new models are founded on delivering continuity of care throughout a citizen’s life, integrating care around the patient through the whole healthcare ecosystem and supporting patient engagement in their care. Health systems require capabilities to support remote care, with dynamic clinical best practices and real-time knowledge sharing at the point of care.

Our Name

The myth says that, in 2000 BC, Daedalus, the first known architect in history, designed and built the Palace of Knossos: an incredible building with an amazing labyrinth constructed inside. The labyrinth represents the journey to prosperity and the search for knowledge. In 1220 AD, the first Gothic cathedral was completed in Chartres (France). This amazing building, once again with a labyrinth inside, represents the journey to knowledge.Dedalus is the name of our company. It is written in Latin, the universal language of Europe and the Middle East for more than 1500 years. The Dedalus company seeks to create a world-leading community based on the experience and expertise of our clients and our team that together will forge a pathway to advance knowledge and tackle the opportunities of modern healthcare.Our passion and mission, expressed in our software-based solutions, is to enable healthcare professionals to build and share clinical knowledge.Every day, we do something special by helping carers and health professionals to provide better care for the communities they serve.LIFE FLOWS THROUGH OUR SOFTWARE

We are currently looking for a Quality Assurance & Regulatory Affairs Post Market Specialist (m/f/d).

As Quality and Regulatory Professional and member of an international team you will ensure quality, regulatory compliance, safety and efficacy of our medical devices and non-medical products.

Your Challenge:

• Ensure regulatory compliance of our post market activities, managing our Health IT software medical devices
• As key member of our international Product Quality Management Teams, you safeguard the resolution of customer complaints escalated for our medical devices and other business critical products
• You drive and guide the cross functional teams addressing product issues and defining and implementing effective preventive and corrective actions
• You drive and ensure compliant and timely resolution of vigilance related tasks like incident and trend reporting, reportable corrections and recalls for all applicable regulatory agencies
• You coordinate and conduct Post Market Surveillance activities and prepare and approve formal written reports, expressing opinions on the adequacy and effectiveness of the system and activity reviewed
• You ensure that customer and service communication is regulatory compliant and accurate
• You carry on regular trend analysis, reporting on product quality in our customer base to support senior management in taking effective decision for quality improvements
• In our fast-growing business segment, your regulatory consulting is key in continuous improvement of our business processes

Your Profile:

• University Degree (preferably in Biomedical Engineering and Computer Science)
• Previous experience, in analogous role, gained in a regulated industry, preferably in the field of medical device production
• Familiar with international regulations and standards pertaining to medical devices development and servicing; familiarity with ISO 9001, ISO 13485, ISO 14971, MDR and ability to interpret and work with regulations and standards
• Exposure to medical device risk management processes, CAPA, Vigilance Management, Post Market Surveillance and software development
• Team player with excellent interpersonal, collaboration, negotiation, conflict resolution, relationship-building, and communication skills
• Self-starter attitude, strong organizational skills, and the ability to meet deadlines
• Knowledge of data analysis and statistical techniques, knowledge of R programming language is an asset
• Very good English verbal and written language skills (nice to have: good command of German and/or French)

• Location: Italy (Bologna office preferably) / Home Based