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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:
-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.
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

BioFire Diagnostics, LLC. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioFire Diagnostics’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).