Quality and Regulatory Affairs Engineer – CDD remplacement d’un congé maternité

TheraPanacea is a medical technology company using AI to improve cancer care, with a focus on radiotherapy. We build solutions that work alongside existing systems to help clinicians plan and deliver treatment more efficiently and consistently. Our goal is simple: support care teams by reducing routine workload and helping them focus on what matters most - patients.

Missions:

• Contribute to the maintenance of our quality system according to the European regulation applicable to medical devices (MDR 2017/745), 21 CFR 820 and any other international standards if required
• Manage and optimize the quality management system according to the ISO13485 standard with a view to extending the fields of applications currently covered by our certification
• Manage and optimize the information security management system according to the ISO27001 standard (and, also, HDS, HIPAA…)
• Write and maintain controlled documents
• Monitoring of key performance indicators
• Create training modules on quality processes and associated assessments.
• Prepare and participate in management reviews and audits (internal and external).
• Participate in the development and follow-up of preventive/corrective quality action plans
• Support teams in the development and application of controlled documents for them and approve them
• Ensure compliance with the List of applicable standards and regulations of the company
• Ensure regulatory watch and the application of new regulations in EU and also internationally
• Help define and implement the company’s product certification policy in Europe and internationally
• Ensure communication with distributors, sponsors, local representative, competent authority and/or consultants to register products and maintain products’ registration internationally

Required skills:

• Knowledge of the environment of medical devices in oncology and/or neurology
• Open, attentive and with good written and oral communication skills
• Autonomous, structured and rigorous
• Qualities of facilitator in an evolving and rapid context
• Strong organizational skills
• More than 2 years experience in quality and regulation in the field of software-like medical devices, medical platform in Europe
• Desired experience on international certification
• Fluency in English

Desired regulatory skills:

• Good knowledge on Medical device regulation, Quality management system ISO 13485, EN 62304, EN 82304 and EN 14971
• Knowledge on 21 CFR 820, 510(k) process, HDS and ISO 27001 is a plus