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.
The selected candidate will work closely with the administration and development teams to ensure traceability, document control and compliance across all phases of our design and development lifecycle.
Applications are open from March 25th to April 30th, 2025.
ABOUT LIVGEMINI
LivGemini is an innovative start-up based in Italy focused on developing software solutions based on AI and Digital Twin technologies to support cardiovascular surgeons in diagnosis and pre-operative planning. Thanks to the entrepreneurial initiative, LivGemini has been recognized with the Italian Innovation Award in the MedTech category in 2023. Our mission is to revolutionize how clinicians plan and perform cardiovascular surgical procedures by integrating in-silico models. We envision a future where each patient receives a personalized treatment based on his anatomical and physiological features, significantly reducing complication risks and enhancing precision for improved clinical outcomes. Our team includes biomedical engineers, software developers and regulatory professionals working closely with surgeons and hospitals across Europe.
ABOUT THE JOB
The candidate will:
1. 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.
2. Support documentation activities related to Design History Files (DHF), Standard Operating Procedures (SOPs), Technical Files (TF), and Risk Management Files (RMF).
3. Help ensuring traceability across development, validation, and clinical phases of the software lifecycle.
4. Contribute to internal audits and assist in the preparation for external assessments.
5. Track non-conformities, manage CAPA, and support continuous improvement initiatives.
6. Support the team in ensuring GDPR compliance across data handling workflows and documentation.
7. Interface with partner hospitals to ensure data traceability and compliance during clinical collaboration.
8. Support communication efforts, including preparation of materials aligned with regulatory and clinical standards.
9. Be 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 Rome or Viterbo, depending on team and project needs. 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
1. Master's degree in Management Engineering, Economics, Biomedical Engineering, or related fields.
2. Interest and/or experience with Medical Device Regulation (EU 2017/745), or quality standards for healthcare.
3. Good interpersonal and communication skills.
4. Attention to detail, excellent organizational skills and ability to work autonomously.
5. Familiarity with CRM tools (Atlassian), documentation tools, spreadsheets.
6. Fluency in English and Italian (written and spoken).
7. Good knowledge of the Microsoft Office suite.
8. Knowledge of QMS (ISO 13485) is preferable.
5 COMPELLING REASONS TO JOIN LIVGEMINI
1. Impact: contribute to ground-breaking advances of in-silico solutions that will transform the medical device industry and deliver innovations for the patients’ healthcare and well-being.
2. Entrepreneurial Environment: be a significant part of a cutting-edge start-up that encourages creativity and proactive attitude.
3. Research-Driven Innovation: collaborate with a world-class scientific team to influence the development of products and services based on state-of-the-art research.
4. Upskilling and Scaling: gain valuable training and opportunities for rapid scaling within the start-up.
5. Flexibility: enjoy a flexible goal-oriented work environment, complemented by hybrid working opportunities.
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