Post-Market Surveillance and Vigilance Manager (Quality Assurance & Regulatory Affairs)

Description

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 Post-Market Surveillance and Vigilance Manager (m/f/d).

The Resource, within the QARA Italy Team, reports to the PRRC and will interface with all the areas involved in any capacity in Company certifications, customer service, RGQ, RDM, CISO, security architects, DPO and RUP, management, certification bodies, Global Department (Globa QARA, Global Product BU, etc.), distributors and associated Companies.

The Post-Market Surveillance and Vigilance Manager aim is to provide leadership and subject matter expertise to ensure that an effective Post-Market Surveillance (PMS) and Vigilance System is successfully implemented and maintained for all medical devices manufactured, marketed, distributed and serviced by Dedalus Italia.

Main tasks:

• Managing the Post-Market Surveillance process and the derivelables
• Ensuring timely and accurate processing fo PMS data collection, plans and periodic reporting
• Organizing PMS teams, to plan and gather all the information needed for the creation of PMS reports and Plans
• Overseeing the generation of Post-Market Surveillance reports when required by regulatory authorutues (e.g. - MDD, EU- MDR, IVDR, etc.)
• Maintaining current knowledge on global regulatory requirements for PMS reporting
• Ensuring the communication of PMS result to product Teams and Top Management
• Representing the area as a subject matter expert in support of internal and external audits
• Providing functional management for PMS staff, including goals, projects, feedback, coaching and performance reviews
• Participating in the definition of global policies, programs and directives of Top Management
• Supporting regulatory affairs activities
• Ensuring the Post-Market Clinical Follow-Up (PMCF) activities are clearly documented within relevant PMSPs shared with clinical analysts and aligned with Notified Bodies
• Leveraging Post-Market data to drive corrective and preventive actions and product enhancement
• Identifying the reportable Avers Event with support of clinical experts
• Executing and managing the process for evalutating, identifying and reporting adverse events to relevant authorities
• Leading the cross-functional teams to work out proper reports and to handle all the "Recall and Correction" in a timely manner
• Ensuring that all the adverse events are handled in a timely manner and in compliance with the Regulations and Company's Requirements
• Performing Customer/Competent Authority communication with the preparation and submission for medical device incidents and field safety corrective actions
• Collaborating with other Corporate Figures on Vigilance activities and being part of the Vigilance audit
• Supporting the Risk Management, HHE and other relevant processes
• Defending the complaint handling, adverse event and other related processes to internal and external investagators and auditors
• Reviewing complaints to ensure the presence of all of the information needed for Reporting/Medical Device Reports
• Maintaining and feeding the Vigilance activities conducted in the EUDAMED system

Required Skills:

• University Degree in Engineering, Computer Science, LifeScience, Biostatistics or similar
• At least 5 years of previous experience in analogous role
• Experience gained in a regulated industry, preferably medical device related, holding a position in project management, quality management or QARA related
• Strong background with complaint handling, Post-Market Surveillance, Vigilance assessment regulations and requirements, Vigilance reporting regulations and requirements
• Knowledge of CAPA/NC regulations and requirements
• Knowledge of usability, safety and product related standards
• Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements, including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive and New Medical Device Regulation MDR IVDR
• Proficient computer skills: MS Office (very good Excel skills mandatory)
• Sound command of English
• Knowledge of software development methodologies and practices
• Willing to make business trips, both in Italy and Abroad, when needed

Other important requiriments are:

• Excellent organizational skills and attention to details
• Able to maintain strict confidentiality of sensitive data, records, files and conversations
• Ability to effectively interact with individuals/groups at all levels in a multifunctional and multicultural environments
• Self-motivated and able to graps new concepts and learn quickly
• Ability to motivate others and falicitate a positive work environment and to manage projects and deliverables with a high level of accuracy and completeness
• Able to solve problems while exercising sound judgement and timely decision-making actions
• Strong verbal and written communication skills

It will be a plus in the selection process:

• Previous experience in the ICT Healthcare Industry
• Awareness of ISO 27001 GDPR
• ISO 13485 Lead Auditor Certification or other relevant qualifications