- 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
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International Regulatory Affairs Specialist/Senior Regulatory Affairs Specialist - Hazelwood, United States - bioMérieux SA
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 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: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:
Regulatory Affairs Specialist: 3+ years of professional experience in regulatory affairs, either in medical devices or in a "Region" position.
You have a professional level of spoken and written for both English and Spanish. You have high level of organization in your work, are detail oriented with good communication skills. You are also able to change easily your priorities and work on many subjects at the same time.The level you qualify for will be determined in the interview process
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