Chargé d'affaires réglementaires

About the role

Mines Saint-Étienne is seeking a regulatory affairs officer to join the Centre Ingénierie Santé and the MedTechLab. The role involves securing the development, experimentation, and market entry of innovative health products, including medical devices and digital health solutions. You will support R&D projects, manage regulatory strategy, and ensure compliance with quality standards and clinical research requirements.

Responsibilities

• Control the compliance of activities and processes against applicable standards and contribute to quality system documentation.
• Identify applicable norms and regulations for research projects and coordinate regulatory monitoring with partners.
• Support the implementation of ISO 14155, ISO 13485, and ISO 14971 standards for clinical studies and quality management.
• Supervise and draft technical files for CE marking and manage post-market surveillance.
• Ensure project compliance with GDPR in collaboration with data protection officers.
• Prepare and lead quality and regulatory meetings and contribute to steering committees.

Required skills

• Regulatory affairs
• Quality management
• Medical devices
• ISO 13485
• ISO 14971
• ISO 14155
• Clinical research
• GDPR
• Technical documentation
• Risk analysis

Nice to have

• MDR 2017/745
• IVDR 2017/746
• AI Act
• Cybersecurity
• Scientific English

Qualifications

• Licence professionnelle in regulatory affairs, health law, or quality
• Master 1 or Master 2 in regulatory affairs, health law, or quality
• Equivalent professional training

Benefits

• 49 days of leave and RTT
• 75% public transport reimbursement
• Carpooling support
• Cycling support

About the Company

Mines Saint-Étienne is a leading French engineering school and a member of the Institut Mines-Télécom. The institution focuses on industrial, digital, and environmental challenges, combining academic excellence with research and societal impact.