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1 VAGA DE Médico EM São Paulo / SP
Função/cargo da vaga:
Médico
Empresa:
Nome da empresa disponível para cadastrados.
Salário:
A combinar
Cidade/Estado:
São Paulo / SP
Regime de contrato:
Efetivo/CLT
Descrição da vaga:
Coordinates and ensures proper submission and approvals of various medical device or other categories of products to government regulatory agencies, organizing and balancing a multitude of projects simultaneously.- Coordinates the work of ra specialists to ensure submission is done properly and in timely manner- Selects and manages external consulting services to prepare files in same conditions than internal as needed- Supports regional team on product submissions schedules, prioritization, and pipeline management.- Supports regional team on requests and follow-Up of documentation provided by ocs to prepare registration dossiers- Act as liaison for franchises to support business plans and regulatory needs- Serves as a technical expert within job function- Prepare and lead training for ra specialists- Propose innovative strategies/solutions for technical files and submission to fulfill requirements and be in compliance with regulatory agency requirements- Participate in multifunctional teams to establish regulatory strategic plans with mínimal guidance- Assist in the development and implementation of regulatory strategies with team representatives and with the regulatory affairs manager.- Prepare and submit proper regulatory documents and technical files to moh with mínimal supervision- Prepare alert communications according to registration process progress and findings during this- Lead specific projects/requests to ensure alignment with business goals and timely responses- Coordinate information on several projects simultaneously- Interacts with other jj personnel, government agencies in a professional, decisive, & articulate manner.- Scan and influence the external environment.- Represent j&j at local moh meetings and external organizations- Provide assistance with establishment registration licenses.- Coordinate/assist in the review and analysis of market licenses and labeling to set up product codes status- Ensure that regulatory databases and labeling databases are well updated as per submissions and approvals received- May identify and communicate new regulatory/legal requirements- Support franchise, bids and functional areas consultations to clarify regulatory questions/conditions- Actively participation and timely delivery results in ra teams to achieve common goals or attend common strategies- Adhere to company and regulatory bodies policies and procedures regarding product introductions, changes and labelingsupport to review promotional materials according to current product registration and moh regulationQualificationsMust have at least 4 years of experience working in regulatory environment (and/or training or equivalent combination of education and experience), preparing submissions for complex devices and a successful track experience in medical devices, pharma background is acceptable.A bachelors degree in engineering, pharmacy or other life science: can be a person with related experience and/or training or equivalent combination of education and with people management is in engineering or biomedicine is desirableknowledge of local & international regulation and processesadvanced degree Lingual: fluent english - Local language (portuguese)advanced pc skillsPrimary locationBrazil-São paulo-São paulo- OrganizationJ&j do brasil indústria e comércio de produtos para saúde ltda. (7600)Job functionRegulatory affairsRequisition idw.
Cód. 10036384
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