Pharmacien affaires réglementaires et qualité - Dispositifs médicaux

About the role

IMM is seeking a Pharmacist for Regulatory Affairs and Quality to ensure the compliance of medical devices with MDR 2017/745 and LEA standards. The role involves managing quality and safety requirements, overseeing ISO 13485 certification, and supervising vigilance actions. The successful candidate will also lead clinical studies, manage a small team, and contribute to the company's CSR policy.

Responsibilities

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

Required skills

• Regulatory Affairs
• Quality Assurance
• 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 assembles and distributes infusion and enteral nutrition medical devices. For 30 years, the company has provided high-standard medical solutions for home and hospital patient care, focusing on therapies such as antibiotic treatment, hydration, and chemotherapy.