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

Therapanacea; Paris; On-site; EUR 70,000 - 90,000; Full time

Job summary

TheraPanacea, a medical technology company focused on AI to improve cancer care, is seeking a Regulatory & Quality professional in France. The role ensures compliance with MDR and global standards, maintains the quality and information security management systems, and supports the development of controlled documents and training materials.

The ideal candidate has 2+ years in quality/regulation for software-like medical devices in Europe, is autonomous and highly organized, and communicates

Qualifications

• 2+ years of quality and regulation experience in software-like medical devices or medical platforms in Europe.
• Fluency in English (written and spoken).
• Autonomous, structured, and rigorous with strong organizational skills.
• Experience with international certifications is a plus.

Responsibilities

• Contribute to maintaining the quality system per MDR 2017/745 and ISO13485.
• Manage and optimize the quality management system toward broader applications.
• Oversee information security management per ISO27001 (and related standards).
• Write and maintain controlled documents.
• Monitor key performance indicators and prepare reports.
• Create training modules on quality processes and assessments.

Skills

Regulatory compliance

ISO 13485

MDR 2017/745

21 CFR 820

Information security awareness

Communication skills

Project management

Job description

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