Regulatory Affairs Manager

2 semanas atrás

São Paulo, Brasil Abbott Tempo inteiro

The Opportunity

This position works out of our São Paulo location in the Diagnostic Division.

As a RA Manager you’ll have to ensure that all imported/marketed products by Core Diagnostic, Molecular and Point of Care Divisions are registered with the Regulatory Authority in compliance with the current sanitary regulations.


What You’ll Do
1. Develop regulatory strategies and implementation plans for the preparation and submission of new product registrations, registration modifications, renewals, GMP certification, product certification and company licensing.
2. Direct the preparation and submission of product regulatory registration and certification (Anvisa, Anatel, Inmetro), and provide responses to regulatory agencies regarding product information, reports, or correspondence.
3. Maintain current knowledge of relevant regulations, including proposed and final rules. 
4. Monitor regulatory affairs activities to ensure that they are aligned with corporate needs, and current regulatory requirements.
5. Develop relationships with city, state and federal regulatory agencies to learn about, influence and analyze the potential impacts of proposed and final regulations. 
6. Represent Abbott CoreDx in trade associations and international regulatory forums.
7. Provide regulatory guidance to departments or project teams regarding design, development, evaluation, or marketing of products.
8. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
9. Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
10. Establish regulatory priorities or budgets, allocate resources and workloads, and report forecasts and actuals.
11. Support internal and external audits, regulatory agency inspections, discoveries and depositions pertaining to regulatory requirements and processes.
12. Technical Responsible: May act as Technical Responsible or Co-Techical responsible of the affiliate for IVD products.

Required Qualifications

Bachelor's Degree in Pharmaceutical Sciences or related discipline. Superior Degree in Health Sciences or MBA is a differential.
Fluent in English (spoken and written). 
Technical expertise on the Brazilian regulatory framework and sanitary regulations for Medical Devices and/or IVDs.
Skilled in Microsoft Excel, Power Point and Word.
Skilled at leading self and leading others.

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