No more applications are being accepted for this job
- 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
- Bachelor's Degree in a scientific discipline
- The ability to speak and write in both Spanish and English is required.
International Regulatory Affairs Specialist - Salt Lake City, United States - Biomerieux S.A.
Description
What will be your activities at bioMrieux?The Regulatory Affairs Market team is looking for a Regulatory Affairs Specialist 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.
Reporting to the Regulatory Affairs Market Manager, your main responsibilities will be:Position Requirements:
Regulatory Affairs Specialist: 1+ years of professional experience in regulatory affairs, either in medical devices or in a "Region" position.
#J-18808-Ljbffr