Regulatory Affairs Specialist F/m 1
il y a 1 semaine
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.
- 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
**What is your profile ?
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