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Responsable Qualité et Affaires Réglementaires – F/H

Présentation société

inHEART propose le « Google Maps » des interventions cardiaques sur les troubles du rythme cardiaque.

Créé en 2017, inHEART développe et commercialise une solution logicielle sur le cloud de traitement et de visualisation d’images médicales qui permet de cartographier en 3D le coeur d’un patient. Cette carte numérique 3D du coeur du patient permet de mieux planifier et guider les interventions d’ablation par cathéter sur les troubles du rythme cardiaque. Ces interventions en deviennent plus simples, plus rapides et plus efficaces!

La technologie d’inHEART est issue de plus de 10 ans de recherche entre l’IHU Liryc et l’Inria, deux centre leaders dans le monde respectivement en électrophysiologie cardiaque et en traitement d’images médicales.

La vision d’inHEART est de faire le pont entre la radiologie et la cardiologie pour devenir un leader mondial de l’aide au diagnostic, de la planification thérapeutique et de la navigation interventionnelle pour les troubles du rythme cardiaque.

Management

• Define regulatory strategy in collaboration with top management
• Ensure the responsibility of Management Representative and PRRC
• Maintaining and coordinating the Management Review process, including routine reporting
• Supervise the Quality team

QMS

• Maintain the quality management system (QMS) in compliance with ISO 13485, MDR 2017/745 and 21 CFR Part 820
• Coordinate internal audits and liaising with Notified Bodies for external audits
• Manage non-conformities (NC) and associated corrective and preventive actions (CAPA)
• Oversee the risk management

Regulatory Affairs

• Manage Technical Documentation and act as PRRC
• Prepare regulatory approvals (including 510(k) submissions) and interact with distributors, sponsors and other stakeholders
• Act as the point of contact for regulatory bodies such as the ANSM and FDA

Coordination across teams

• Coordinate with all business areas involved in the software development lifecycle, from research, through design and maintenance, sales and after-sales.
• Provide guidance, assistance and training to employees on quality and compliance issues
• Continuously monitor and communicate regulatory changes

Descriptif du profil

Education: Master’s degree in engineering, physics, biology or related field of study

Experience: 10+ years of experience in quality and regulatory affairs for medical devices

Required skills:

– Knowledge and experience of medical device standards (ISO 13485, ISO 14971, IEC 62304, IEC 62366) and regulations (EU MDR 2017/745, FDA with 21 CFR Part 820), preferably applied to software as a medical device.

– Previous experience in 510(k) submission.

– Communication skills and knowledge in project management.

– Proficiency in English (verbal and written).

Desired skills: Experience with SaMD, knowledge of MDSAP, knowledge of privacy rules (GDPR, SOC2, HIPAA).

You are interested in an experience with the dynamic and agile environment of a startup in which you can take advantage of your initiative and autonomy, your problem-solving skills, your result-oriented mindset, your curiosity, and your creativity. You are looking for a job in which your contribution will have a direct impact not only on the company activity, but also on the patient care.

Join us!

Postuler

Imane Houda
jobs@inheartmedical.com

https://www.inheartmedical.com