Analista de Assuntos Regulatórios Sênior

Job Description

The senior regulatory affairs analyst is a highly skilled professional that plans, reasons, constructs, and conducts a very broad array of regulatory submissions in many different territories, for a variety of devices, to guarantee the compliance and accuracy of timely communicated technical information that is aimed at competent authorities and conformity assessment bodies, while internally safeguarding the alignment of such information with a variety of technical and support teams of the company. He/She also deals with the regulatory intelligence that supports those activities, so that information is always up to date and in conformity, both in terms of adequacy and achievement of regulatory expectations.

• Operationalize, review, and provide support to less experienced team members for preclinical regulatory submissions, especially product registrations, changes, and revalidations, as required, in Latin America.
• Prepare such subm...