Pharmacien affaires réglementaires et qualité - Dispositifs médicaux

About the role

IMM is a French SME specializing in infusion and enteral nutrition medical devices. We are seeking a Regulatory Affairs and Quality Pharmacist to ensure the regulatory compliance of our medical devices, manage quality standards, and support our development. The role involves overseeing regulatory certifications, managing vigilance actions, and leading clinical study initiatives.

Responsibilities

• Ensure regulatory compliance of medical devices according to MDR 2017/745 and LEA standards
• Manage quality and safety requirements and product performance
• Lead the ISO 13485 certification process in coordination with the certifying body
• Conduct regulatory monitoring for European product certifications
• Supervise materiovigilance and health vigilance actions
• Participate in clinical study management and conduct training for clients
• Develop CSR policy and manage a team of two project managers

Required skills

• Regulatory Affairs
• Quality Management
• MDR 2017/745
• ISO 13485
• Materiovigilance
• English

Qualifications

• Pharmacist degree
• Specialization in regulatory affairs or quality

About the Company

IMM (International Medical Mediation) is a French SME based in Belfort that has been a market reference for 30 years in the assembly and distribution of infusion and enteral nutrition medical devices for home and hospital care.