Senior Ra Specialist

4 semanas atrás

Barueri, São Paulo, Brasil Agilent Technologies, Inc. Tempo inteiro
The position helps to ensure products are received, licensed, and delivered by Agilent are performed in accordance with Brazil regulatory and quality standards and regulations. As a member of the Agilent Global Regulatory Team, you will provide support to business teams for IVD registrations in Latin America such as the following:
Develops and implements programs and processes to ensure that company products are safe, legal, and meet customer expectations for compliance with national/regional/global regulations.
Prepares document packages for regulatory submissions and listings to ensure alignment and compliance with local and regional registration requirements and company policies.
Monitor regulations and changes in the regulatory environment and participate on discussions related to regulation changes (Trade Associations, ANVISA) and anticipate, assess, and communicate changes.
Compile materials required in submissions, license renewal and annual registrations.
Leads regulatory projects requiring coordination with other functions, third parties
Provide proper regulatory advice to main stakeholders considering business needs.
Monitor regulations and changes in the regulatory environment and participate on discussions related to regulation changes (Trade Associations, ANVISA) to keep internal stakeholders updated on potential risks and opportunities that could impact ongoing and future projects.
Review and approve promotional and non-promotional materials according with local regulations and Agilent procedures.
Agilent is seeking a highly skilled, motivated and customer focused professional to join our Brazil team.
**Key Responsibilities**
- Register IVD and CDx submissions with local authorities.
- Coordinate preparation of product documentation needed for obtaining Brazil regulatory permits, licenses, and registrations.
- Maintain Brazil QMS is aligned with Agilent QMS.
- Monitor for new regulations.
- Maintain and track product compliance documentation on regulated products.
- Bachelor's degree in Pharmaceutical Sciences.
- A minimum of 8 years of relevant experience in regulated environment.
- Experience with audits from regulatory authorities and notified bodies.
- Professional registration with CRF (Regional Council of Pharmacy.
- Knowledge and experience with Brazil IVD regulatory standards and compliance requirements.
- Demonstrated teamwork skills and ability to lead, collaborate and work effectively in teams across different businesses, functions, and geographies.
- QMS experience for medical devices industry.
- Advanced written/spoken communication in English.
- Experience working with global resources across several departments or functions.
- Position is based in Sao Paulo, Brazil.
Preferred Qualifications
- Working knowledge of design controls and knowledge of applicable standards (ISO 13485 and 14791).
- Experience working with regulated products; knowledge of ISO Quality standards and Brazil medical device regulations.
- Excellent communication, strong project management and presentation skills.

  • Senior Business Development Specialist

    Há 3 dias

    Barueri, São Paulo, Brasil beBeeSolution Tempo inteiro R$150.000 - R$200.000

    As a Senior Business Development Specialist, you will be responsible for interpreting business needs and delivering effective technical solutions.This role involves managing bids, creating engaging presentations, and collaborating with solution teams to develop proposals. You will also support Relationship Managers in generating new business and building...

  • Sr Specialist Accounting

    Há 5 dias

    Barueri, São Paulo, Brasil adidas Tempo inteiro

    Join to apply for the SR Specialist Accounting role at adidasJoin to apply for the SR Specialist Accounting role at adidasDirect message the job poster from adidasPURPOSE & OVERALL RELEVANCE FOR THE ORGANIZATIONSecures financial operations by monitoring and approving financial processing, reporting; ensure that accountingrecords and documentation comply...

  • Senior Financial Operations Specialist

    Há 6 horas

    Barueri, São Paulo, Brasil beBeeAccounting Tempo inteiro R$4.000 - R$8.000

    Job DescriptionWe are seeking an experienced Accounting Specialist to join our team. The ideal candidate will have a strong background in financial operations, with expertise in monitoring and approving financial processing, reporting, and ensuring compliance with accounting records and documentation.This role requires the ability to identify variances,...

  • Application Specialist 2

    Há 5 dias

    Barueri, São Paulo, Brasil IFF Tempo inteiro

    Join to apply for the Application Specialist 2 role at IFF Join to apply for the Application Specialist 2 role at IFF Job SummaryAn Application Specialist 2 exhibits independent application and project planning ability, seamlessly integrating creativity, innovation, and presentation skills to provide best in class support to IFF clients. The Specialist...

  • Senior Fund Systems Specialist

    Há 2 dias

    Barueri, São Paulo, Brasil beBeeBusiness Tempo inteiro R$90.000 - R$150.000

    Job Summary:We are seeking a highly skilled Business System Analyst to join our team.This is an exciting opportunity for someone who is passionate about process improvement and has excellent analytical skills.About the Role:The successful candidate will be responsible for providing day-to-day support for Investran and other specialist fund systems, as well...

  • Senior Data Visualization Specialist

    Há 4 dias

    Barueri, São Paulo, Brasil beBeeDataVisualization Tempo inteiro R$52.000 - R$84.000

    Job DescriptionAs a senior data visualization developer, you will be responsible for creating advanced data visualizations solutions using AWS services. Your expertise in hosting and developing data visualization solutions will play a key role in driving our business forward.Our ideal candidate will have strong experience in designing and implementing data...

  • Business Process Improvement Specialist

    Há 3 dias

    Barueri, São Paulo, Brasil beBeeInternalControls Tempo inteiro R$180.000 - R$230.000

    Job DescriptionWe are seeking a highly skilled and experienced Internal Controls Specialist to join our team. As a key member of our Corporate Governance department, you will play a vital role in improving the efficiency, transparency, and effectiveness of business processes.Your responsibilities will include developing, supporting, and leading...

  • Accounting Specialist Senior

    Há 2 dias

    Barueri, São Paulo, Brasil beBeeAccounting Tempo inteiro R$72.000 - R$136.000

    Financial ExcellenceWe are seeking a highly skilled accounting professional to play a pivotal role in shaping our organization's financial landscape. This individual will be responsible for establishing and maintaining robust financial reporting and practices, ensuring compliance with relevant regulations.Key Responsibilities:Develop and maintain accurate...

  • Analista de Dados Sênior

    3 semanas atrás

    Barueri, São Paulo, Brasil UX Group Tempo inteiro

    A Reals é uma empresa que proporciona uma experiência de entretenimento digital com excelência, responsabilidade e impacto real na vida das pessoas – gerando crescimento com ética, cuidado e alta performance. Com suas operações iniciadas em outubro de 2022, em apenas 7 meses, a Reals se tornou uma das empresas de entretenimento que mais crescem no...

  • Analista de Dados Sênior

    2 semanas atrás

    Barueri, São Paulo, Brasil UX Group Tempo inteiro

    A Reals é uma empresa que proporciona uma experiência de entretenimento digital com excelência, responsabilidade e impacto real na vida das pessoas – gerando crescimento com ética, cuidado e alta performance. Com suas operações iniciadas em outubro de 2022, em apenas 7 meses, a Reals se tornou uma das empresas de entretenimento que mais crescem no...