Post-Market Surveillance And Vigilance Manager BOLOGNA

Post-Market Surveillance And Vigilance Manager
Bologna
Emilia Romagna, BOLOGNA

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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.

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

- 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