Pharmacist Regulatory Affairs and Quality - 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 and located in Belfort (90).

For 30 years, IMM has been supporting healthcare professionals and offering them medical devices that meet the highest standards of requirement. Present in home care and hospital settings, IMM develops devices for administering antibiotic therapy, hydration, or chemotherapy at home, thus allowing patients 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 Director,

• You are responsible for the regulatory compliance of our medical devices with the requirements of MDR 2017/745, LEA, and transparency regulations.

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

• In liaison with the notified body, you will manage the achievement of ISO 13485 certification.

• You will establish regulatory monitoring to get our products certified in various European countries.

• You will supervise actions related to medical device vigilance and health vigilance.

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

• You will develop our CSR policy and manage two project managers.

You hold a pharmacist degree, ideally complemented by a specialization in regulatory affairs and/or quality. You have proven experience in a pharmaceutical laboratory or another company in the medical device sector. You have a strong command of MDR and ISO 13485 standards.

You aspire to join a human-sized structure that can involve 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 conferences or other events. A good command of English is essential.

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