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QARA Specialist – F/H

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Présentation société

Kiro est une start up qui développe un logiciel standalone qui analyse des données de laboratoire et donne au médecin des recommandations d\’examens. 

CE dispositif de Classe I sous MDD, est en cours de marquage CE en Classe IIa sous MDR (Attendu pour Q2 2024). 

To support our growth, we are looking for a highly motivated QARA Specialist to join our team. As medical devices, our AI solutions need to go through a thorough compliance and certification process. As a QARA Specialist you will oversee all aspects of the QMS and product regulatory compliance.

Your role and responsibilities will be:

Quality Management

• Develop and maintain the Quality Management System to ensure compliance with applicable regulations. Participate in Kiro’s QMS continuous improvement and monitor Quality KPI
• Manage NC, CAPA & Complaint process: Drive and collaborate with cross functional team members to develop action plans and adhere to process phase timelines
• Manage Quality Post-market activities: Monitor product performance, providing data to support decisions regarding the safety and effectiveness of the product
• Participate in internal and external regulatory audits
• Provide regular training to the team and foster a culture of compliance and continuous learning within the company
• Manage Product change control process to ensure product compliance throughout their life-cycle: guarantee that regulatory requirements are met and manage technical documentation necessary for product release

 Regulatory Affairs:

• Prepare and submit regulatory documentation to obtain and maintain product approvals and certifications
• Manage relationships with notified body and regulatory authorities
• Perform regulatory and standard watch
• Provide regulatory support to sales and marketing (promotion & communication)
• Participate to the design and evaluation of clinical activities

Descriptif du profil

• 3+ years experience in QARA  for medical devices
• Master’s degree in engineering, biomedical sciences, or in the field of Regulatory Affairs or Quality assurance
• Strong knowledge of regulations and standards related to medical device such as (UE)2017/745 MD regulation, QMS standard & regulations (ISO 13485, 21 CFR), and product related standards such as ISO 14971, IEC 62366, IEC 62304 and IEC 82304-1
• You can work autonomously with strong analytical and problem-solving skills and with meticulous attention to detail
• Ability to work collaboratively in cross-functional teams with a great team spirit
• You adapt quickly to new environments and challenges, are willing to take initiatives and strive to continuously improve yourself
• Strong French and English language skills

Postuler

Gaëlle SALAÜN
gaelle.salaun@kiro.bio