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Regulatory Affairs Specialist F/m 1
2 semanas atrás
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.
**RA Specialist LATAM/Canada - RA Market**
**Brief Description**
The Regulatory Affairs Market team is looking for a Regulatory Affairs Officer to support Latin America & Canada region in a dynamic regulatory context.
The Regulatory Affairs Market team composed of 9 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-LATAM region.
**Description**
What will be your activities at bioMérieux?
The Regulatory Affairs Market team is looking for a Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist to support Latin America & Canada region in a dynamic regulatory context.
The Regulatory Affairs Market team composed of 9 people based in France (marcy l’Etoile) and in United States (St Louis) 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-LATAM region.
Reporting to the Regulatory Affairs Market Manager based in France, your main responsibilities will be:
- Be the privileged point of contact point with subsidiaries and distributors. Lead regular follow-ups with the countries (progress of files, new regulations, etc.) and work closely with LATAM Regional RA and other 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.
- Follow-up 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 for transversal projects
Position Requirements:
- Bachelor's Degree in a scientific discipline
- Regulatory Affairs Specialist: 1+ years of professional experience in regulatory affairs, either in medical devices or in a "Region" position.
- Senior Regulatory Affairs Specialist: 3+ years of professional experience in regulatory affairs, either in medical devices or in a "Region" position.
- The ability to speak and write in both Spanish and English is required.
