Alternance Qualite et Affaires Reglementaires H​/F

Post Mission

Reporting to the Director of Quality and Regulatory Affairs, you will participate in the following missions:

Quality

• Contribute to the implementation and improvement of the Quality Management System (ISO 13485)
• Participate in the management of non-conformities, CAPA, and customer complaints
• Take part in the validations of processes (production, sterilization)
• Participate in the preparation and execution of internal and external audits
• Monitor quality indicators and contribute to continuous improvement actions
• Raise awareness among teams about good quality practices

Regulatory Affairs

• Participate in maintaining the regulatory compliance of medical devices (MDR 2017/745)
• Contribute to the writing and updating of technical files (CE marking)
• Ensure regulatory and normative surveillance
• Participate in exchanges with health authorities and notified bodies
• Contribute to vigilance activities (monitoring incidents, reporting)
• Verify the regulatory compliance of documents (instructions, marketing materials)

You are preparing a typical Bac +4/5 education in quality, regulatory affairs, or equivalent.

You have a first experience from a traineeship or internship. Knowledge in an industrial environment, ideally in the medical devices, pharmaceutical, or food sectors, would be an advantage.

You show particular interest in current standards and regulations (ISO 13485, MDR, etc.) and wish to invest in an innovative company at the service of health.

You demonstrate rigor, organization, and analytical skills. Your ability to work in a team and across departments, as well as your relational and pedagogical qualities, will allow you to successfully carry out these missions.

You are proficient in English, both written and spoken.

Internship: 12 or 24 months

Start date:

September 2026

Location:

Ercuis (60)