Job Description

Roles & Responsibilities

Regulatory Affairs & Quality Manager

Mission g n rale

• To guarantee regulatory compliance of products and ensure control of the quality system in accordance with national and international requirements applicable to in vitro diagnostic medical devices.

Main responsibilities

• Prepare and maintain the technical files produced.
• Manage the registration procedures with the competent authorities.
• Ensure compliance with the ISO 13485 quality system.
• Manage the document system.
• Participate in the management of product and supplier changes.
• Ensure follow-up on non-conformities and corrective actions.
• Prepare for and support internal and external audits.
• Ensure regulatory monitoring.

Formation

• Pharmacist, quality engineer or master's degree in quality assurance.

Exp rience

• 1-2 years in medical devices, the pharmaceutical industry or health laboratories.

Comp tences

• ISO 13485.
• Documentation technique IVD.
• Document management.
• He hears what is good.
• Mastery of French and technical English.

Conditions

• Languages: Fluent French.
• Good command of technical English (reading scientific documentation and communicating with suppliers).

Personal qualities

• Scientific rigor.
• Analytical and synthesis skills.
• Sense of organization.
• Autonomy and ability to work in a team.
• Curiosit et int r t pour l'innovation.
• Company Industry