World leader in the field of in vitro diagnostics for over 50 years, bioMérieux conceives, develops, produces and markets diagnostics solutions (systems, reagents, software and services) intended for clinical and industrial applications, which determine the origin of a disease or a contamination to improve the health of patients and insure consumer safety.
bioMérieux is present in over 150 countries through 43 subsidiaries and a large network of distributors. More than 90% of our sales are done internationally. Its corporate headquarters are located in Marcy l'Etoile, near Lyon, in France.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture.
We look for candidates whose motivation is to invest in themselves, in the projects of the future, and to participate in a collective adventure led by a pioneering spirit.
We have the commitment to offer our collaborators a working environment which encourages team spirit, with priority given to training and development with international career opportunities.
Our Group offers numerous possibilities: so come and join the 10,000 bioMérieux employees who have already identified with these values!
Regulatory Affairs Specialist - Latin America & Canada
Execute regulatory strategies: Ensure adherence to policies and drive implementation of the regulatory processes as planned at Unit and Region Level.
The position reports to the RA Manager Latin America / Canada, the selected candidate will have the following responsibilities:
Identify and specify the regulatory provisions of Latin America and Canada to provide the concerned structures with solutions.
Support registration schedules consistent with the business strategy, in close collaboration with the subsidiaries
Manage registrations, renewals, and changes for in vitro diagnostic medical devices (Reagents & Instruments)
Contribute to the definition, improvement, updating and implementation of regulatory procedures, mainly those related to obtaining and renewing approvals from the concerned countries.
Stay abreast of evolving regulations and of application requirements and processes
Contribute to provide feedback on the effectiveness of the regulatory processes (strategy, applications review with questions/answers, issues and problem resolution) and contribute to improvement plans.
Studies, Experience, Skills & Qualifications:
Bachelor degree in Science or Engineering.
Minimum of 1 year experience in regulatory affairs, ideally in the field of medical devices IVDs/MDs (reagents and instruments) or 6 months or less with a Master's degree
Working knowledge of regulatory requirements, guidance documents and processes (local/regional)
Preferred but not required: Spanish, French, or Brazilian Portuguese, both written and spoken.
Can demonstrate rigor, organization and responsiveness.
Excellent communication, organizational and problem solving skills required.
Selected individual will be able to manage to organizational priorities and deadlines while being dynamic to adjust to the changing regulatory environment.
Can work in an International environment
Analysis of moderate complexity issue and problem solving.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity.