Quality & Regulatory Affairs Specialist

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For more than 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 46 countries and serve 160 countries with the support of a large distribution network.
Come and join a family-owned global company with a long-term vision, and a human-centered culture.

We are seeking a Quality & Regulatory Affairs Specialist for the Industrial Applications business unit, within an international and multidisciplinary environment.

What will your responsibilities be?

Quality

• Respond to quality requests from pharmaceutical customers (quality agreements, questionnaires), ensuring alignment with the internal quality system.
• Lead the preparation, implementation, and follow-up of these agreements.
• Manage the contract library and train users.
• Monitor applicable standards and references (pharmacopoeias and ISO standards).
• Provide quality support to business unit departments as needed.

Regulatory Affairs

• Manage and update regulatory documentation for market access.
• Contribute to regulatory activities, including strategy, compliance, and dossier preparation (including Type V DMFs).
• Support regulatory contacts within subsidiaries.
• Monitor and interpret applicable regulations for non-IVD instruments.

Who are you?

• Master’s degree (or equivalent) with at least 3 years of experience in quality and/or market access for laboratory equipment.
• Knowledge of the pharmaceutical industry.
• Strong understanding of international regulations and standards for non-IVD instruments.
• Experience in managing quality events.
• Strong rigor and communication skills.
• Good command of French and English (written and spoken).

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.