Regulatory Affairs and Quality Pharmacist - Medical Devices M/F

Assembler and distributor of infusion and enteral nutrition devices, IMM (International Medical Mediation) is a leading French SME in its market, located in Belfort (90). For 30 years, IMM has been working alongside healthcare professionals, offering them medical devices that meet the highest standards of excellence. Present in both home care and hospital settings, IMM develops devices that allow for antibiotic therapy, hydration, or chemotherapy to be administered at home, thus allowing the patient to maintain an optimal quality of life. To support our development, we are looking for our new Regulatory Affairs and Quality Pharmacist M/F.

Under the responsibility of the Manager, You are the guarantor of the regulatory compliance of our medical devices with regard to the requirements of the MDR 2017/745 standards, LEA, and transparency.

You are responsible for compliance with standards, quality and safety requirements, as well as the performance of our products.

In relation with the certification body, you lead the process of obtaining the ISO 13485 standard.

You establish regulatory monitoring to have our products certified in various European countries.

You supervise actions related to materiovigilance and health vigilance.

You participate in the management of clinical studies and lead training sessions and webinars for our clients.

You develop our CSR policy and manage two project officers.

You hold a pharmacy degree, ideally supplemented by a specialization in regulatory affairs and/or quality. You have significant initial experience in a pharmaceutical laboratory or another company in the M.D. sector. You master the MDR and ISO 13485 standards.

You aspire to join a human-sized structure capable of involving you in an ambitious development project. You are proactive and enjoy teamwork. Organized, rigorous, and methodical, you know how to operate in a demanding regulatory environment. You are available to participate in congresses or other events. Good proficiency in English is essential.