Posizione
POSITION SUMMARY
We are looking for a Quality & Regulatory Support Specialist to contribute to the management of our ISO 13485 Quality System and ensure compliance throughout documentation, operations and clinical collaborations.
Applications are open from March 25th to April 30th, 2025.
ABOUT THE JOB
The candidate will:
• Assist the team and the external consulting company with the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO 13485, applicable complementary standards (such as ISO 14971) and GDPR.
• Support documentation activities related to Design History Files (DHF), Standard Operating Procedures (SOPs), Technical Files (TF), and Risk Management Files (RMF).
• Help ensuring traceability across development, validation, and clinical phases of the software lifecycle.
• Contribute to internal audits and assist in the preparation for external assessments.
• Track non-conformities, manage CAPA, and support continuous improvement initiatives.
• Supporting the team in ensuring GDPR compliance across data handling workflows and documentation.
• Interface with partner hospitals to ensure data traceability and compliance during clinical collaboration.
• Support communication efforts, including preparation of materials aligned with regulatory and clinical standards.
• Being available to represent LivGemini at events, workshops and meetings with partners and stakeholders.
The position will be initially part-time (24 hours/week). LivGemini offers a hybrid work arrangement, with partial remote work allowed. The primary workplace will be in Viterbo. Work hours are flexible within the limits of the contractual schedule, as long as participation in meetings and planned activities is ensured. The type of contract and the salary will be commensurate with the candidate's experience in compliance with the relevant Italian regulations (CCNL Commercio). The position is expected to start in mid-May 2025.
REQUIRED QUALIFICATION AND EXPERTISE
• Master's degree in Management Engineering, Economics, Biomedical Engineering, or related fields.
• Interest and/or experience with Medical Device Regulation (EU 2017/745), or quality standards for healthcare
• Good interpersonal and communication skills.
• Attention to detail, excellent organizational skills and ability to work autonomously
• Familiarity with CRM tools (Atlassian), documentation tools, spreadsheets.
• Fluency in English and Italian (written and spoken)
• Good knowledge of the Microsoft Office suite.
• Knowledge of QMS (ISO 13485) is preferable.
Caratteristiche del candidato
Lingue straniereE' richiesta la conoscenza delle seguenti lingue
1. Italiano: madrelingua
2. Inglese: ottimo (C2)
Area disciplinarescientifico,medico,ingegneriaTipo candidatoNeolaureato, Laureato con esperienzaDisponibilità al trasferimentoNon richiestaDisponibilità trasferimento all'esteroNon richiesta