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Regulatory Affairs Specialist in software for Medical Devices - Canada - bioMérieux SA
Description
bioMérieux Inc.Regulatory Affairs officer Latin America / Canada
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.
DescriptionWhat 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.
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