Vaga: Vaga de Designer em Rio de Janeiro/RJ - home office
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Cargo/Função: Designer
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Localização: Rio de Janeiro / RJ
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Salário: a combinar
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Empresa: Confidencial O que é isso?
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Home Office
Descrição Geral
Empresa localizada na cidade de Rio de Janeiro/RJ do ramo Gráfica, contrata Designer.
Atribuições
Senior regulatory affairs specialist, brazil about the role the purpose of the senior regulatory affairs specialist role in brazil is to provide regulatory support and guidance that will enable timely device registrations and helping ensure that cochlear is compliant with premarket and post market regulatory requirements for all cochlear products sold in brazil, including applicable local certifications. This role closely collaborates with global, regional and local roles to ensure regulatory compliance in brazil by providing product support and maintenance. Key accountabilities will include: accountability 1: support regulatory strategy and planning participate in the development and implementation of the regulatory registration plan in brazil, including local certifications, in close cooperation with regional and local functions (such as sales, marketing and clinical) in order to achieve timely regulatory approval and registration of product. Coordinate the maintenance of the registrations and local certifications (electrical, radio frequency) in line with prioritization and renewal plan, in a timely manner. Accountability 2: regulatory submissions and related activities adapt or create technical dossiers appropriate for the local market submissions: independently write executive summaries and compile documents for submissions of all types in line with registration plan. Ensure company business plans are met by organizing the request, approval and maintenance of local certifications (anatel and inmetro) in line with registration and launch plans. Follow up on regulatory applications within agreed timelines, coordinating support for the local distributor in working with regulatory authorities. Provide final documented assessment of any impacts of changes to devices, labeling, or manufacturing processes with an appropriate level of justification. Serve as subject matter expert for global colleagues. Manage timely regulatory submissions and approvals for changes in c
Tipo de Vínculo
Efetivo - Home Office.
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