Regulatory Affairs Specialist F/m - Lyon, France - bioMérieux sa

bioMérieux sa

Entreprise vérifiée

Lyon, France

il y a 1 semaine

Posté par:

Sophie Dupont

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Description

A family-owned company, bioMérieux has grown to become
a world leader in the field of in vitro diagnostics.

For almost 60 years and across the world, we have imagined and developed
innovative diagnostics solutions to
improve public health.

Today, our teams are spread across 45 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.

What will be your activities at bioMérieux?

The Regulatory Affairs Market team is looking for a Regulatory Affairs Officer for EME-AFRICA-ASPAC region in a dynamic regulatory context.

The ASPAC-EMEA- team composed of 7 people is in daily contact with the local regulatory teams (subsidiaries and distributors) in order to guarantee the regulatory compliance of the products (reagents, instruments and software) for EME-AFRICA-ASPAC region.

Reporting to the ASPAC-EMEA Manager, your main responsibilities will be:

Be the privileged point of contact point with subsidiaries and distributors. Coordinate regular follow-ups with the countries (progress of files, new regulations, etc.) and coordination with the Global functions.
Responsible of Regulatory activities for a range of products:
Contribute to the development of the regulatory strategy
Coordinate and prepare the registration and renewal dossier within the defined deadlines in order to send it to the local regulatory contact.
Ensure the traceability of these shipments in the regulatory database and ensure reporting.
Followup of regulatory activities until approvals
Responsible for the regulatory watch of a group of countries in order to identify any change having an impact on the product development and/ or leading to new regulatory activities
Contribute to different working groups

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