Specialist

5 meses atrás

Santo André, Brasil Ansell Tempo inteiro
Job Description - Specialist, Regulatory Compliance.Quality.Regulatory (30006955)

Job Description

Specialist, Regulatory Compliance.Quality.Regulatory-(30006955)

Description

Why Ansell

Ansell is a leading global provider of protection solutions. Our company designs, develops and manufactures a wide range of protection solutions that meet the ever-changing needs and demands of our markets and industries. Protection is our primary concern as millions of people around the world depend on Ansell in their professional and personal lives.

Why we do it

Safety culture is what we believe in Protecting people and Protecting the planet through innovation and sustainability is what we are passionate about. Ansell’s purpose is protection Come join a trusted market leader

Ansell is looking for a Regulatory Affairs Specialist to join our team in Santo André, Brazil

About this opportunity

Role Profile

Position Title: RA Specialist

Job Location: Santo André, Brasil

Job Type: Full-Time

Status: Exempt

Reports toSR Manager, RA – Medical Products

Specific responsibilities include:

This position reports to the SR Manager Regulatory Affairs and provides support in the development and management of regulatory dossiers for submission to the Regulatory Authorities to ensure regulatory certifications, specifically for Brazil.
The function will also work with the Regulatory Affairs Managers/Specialists , LACin helping them to execute the Medical Devicecertification process.In addition, this position is responsible for providing cross functional support for quality management systems to comply with Brazil regulatory requirements for medical devices.These activities include but are not limited to procedure development, corrective and preventive action investigations, data analysis/trending, and other internal projects as they relate to the quality system.This position will also support common quality system functions as needed, such as internal and external audits.

What would this role look like in detail?

1.Preparation and maintenance of regulatory submission dossiers for Brazil compliance certifications for Medical related products in coordination with the Sr Manager RA.

 2.Support to ensure accurate, complete, and timely submissions to regulatory agencies

 3.Gathering necessary documents from each department, in coordination with the Sr Manager Regulatory Affairs.

 4.Liaise with Regulatory Authorities for any follow up requirements regarding regulatory submissions

 5.Assisting with Regulatory Authority Visits and External Notified Body audits

 6.Post Market Surveillance – facilitate import/export regulatory activities for Ansell Products to ensure compliance with government regulations as well as coordinate recalls and detentions as required.

 7.Work in collaboration with Product Management, R&D, Legal and QARA management teams to facilitate appropriate regulatory actions throughout the product life cycle

 8.Continually appraise the Regulatory Affairs department of matters of importance in the incumbent’s area of responsibility that impact on the business, or which is necessary to meet the required objectives.

 9.Provide Customer support for regulatory related information including compliance or clearance related information

10.Work with the Sr Manager RA to provide regulatory assessment reviews and approvals as an input to overall business planning / strategies throughout the product lifecycle.

11.Provide the required regulatory support towards the RA employees in Americas Regionin the execution of the relevant Medical certification process

12.Maintenance of the Global Regulatory Affairs databases & similar systems used by Global Regulatory Affairs such as the website, Asset Bank, Trackwise, etc.

13.Supports quality initiatives in creating quality plans, meaningful metrics, and procedures in accordance with regulatory authority requirements.

14.Collaborates with multiple business unit and regional teams in order to formulate procedures, assist is projects and provide input to the quality management system.

15.Other relevant Regulatory Affairs Duties, as required

What will you bring to Ansell?

Education

Associates or Bachelor’s Degree in a relevant scientific/technical field pharmacy, chemistry, chemical engineering etc.

Job Experience

Preferably, minimum 2 years in a Regulatory Affairs environment within pharmaceutical, cosmetics and / or medical devices. Medical Devices preferred

Other relevant experience and specialized training will be considered.

Knowledge and Skills

Understanding of local Medical regulations as applicable to Ansell’s business

Understanding of products standards

Exposure to Quality Assurance methodologies

Strong PC literacy

Desirable Job Competencies

Positive, “can do”, flexible attitude.

Collaboration and teamwork when working with key partners

Problem solver to assist the business in ensuring regulatory compliance

Team player

Results Oriented

Good communication and interpersonal skills

What will you get from Ansell?

·Competitive compensation plan, base salary, and annual incentive

·Health Benefits: medical, dental and wellness programs

·Collaborative and Innovative work environment

Equal Opportunity Employer

️At Ansell we value diversity and understand that what adds up is precisely varied ideas and points of view. Therefore, race, color, religion, creed, national origin, sex and gender identity, nationality, disability or mental disability, sexual orientation, ancestry, or age, will not prevent you from being part of our team.

The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Our Commitment to Diversity Equity and Inclusion

Ansell’s vision is about creating safe spaces where diverse perspectives are valued alongside individual contributions. It is our view that togetherness prevails over individuality.

When we say that everyone deserves to belong, feel included and empowered at work, it's not just words. Rather, it’s what drives Ansell as an organization towards a workforce that reflects the diversity of our community, it’s what drives us to serve our customers and stakeholders with pride, and it’s also what differentiates Ansell. We believe everyone, no matter how that person self-identifies, deserves an opportunity to achieve success.

  • Vaga de Consultor de Vendas Externa

    Há 5 dias

    Santo André, São Paulo, Brasil Catho Online Ltda. - BR - Specialist Tempo inteiro

    Catho Online Ltda. - BR - Specialist está em busca de um profissional qualificado para o cargo de Consultor de Vendas Externa.ResponsabilidadesCaptura de clientes: O candidato deve ter habilidade para capturar clientes e realizar as vendas dos produtos e serviços da empresa, garantindo o atingimento de metas de faturamento da organização.Elaboração de...

  • Marketing Specialist

    Há 5 dias

    Santo André, São Paulo, Brasil Motivalli Tempo inteiro

    Job Description:As a Marketing Specialist - Brand Development, you will be responsible for developing and implementing marketing strategies to promote our brand and products.Key Responsibilities:Develop and execute marketing plans to increase brand awareness and drive salesCollaborate with cross-functional teams to align marketing efforts with business...

  • Education Support Specialist

    2 semanas atrás

    Santo André, São Paulo, Brasil Red House International School Tempo inteiro

    Education Support SpecialistWe are seeking a dedicated and passionate Education Support Specialist to join our team at Red House International School. As a key member of our educational community, you will provide essential support to our Head Teachers in teaching classes, preparing content, and managing students in school environments.Key...

  • Education Support Specialist

    2 semanas atrás

    Santo André, São Paulo, Brasil Red House International School Tempo inteiro

    Education Support SpecialistWe are seeking a dedicated and passionate Education Support Specialist to join our team at Red House International School. As a key member of our educational community, you will provide essential support to our Head Teachers in teaching classes, preparing content, and managing students in school environments.Key...

  • Fibers Production Specialist

    2 semanas atrás

    Santo André, São Paulo, Brasil Solvay (FR) Tempo inteiro

    Solvay is a leading chemical company that thrives on the power of collaboration. Our team of experts is dedicated to creating innovative solutions that improve lives while preserving the planet's beauty.About the roleOur Polymerization team is a dynamic group of 42 professionals working together to drive innovation and excellence.We are seeking a skilled...

  • Senior Marine Biodiversity Conservation Specialist

    2 meses atrás

    Santo André, São Paulo, Brasil ACDIVOCA Tempo inteiro

    Job Title: Senior Marine Biodiversity Conservation SpecialistA CDI/VOCA is seeking a highly skilled and experienced Senior Marine Biodiversity Conservation Specialist to support the coordination and management of a marine biodiversity conservation project in Timor-Leste. The project aims to strengthen biodiversity conservation efforts in the marine...

  • Senior Human Resources Specialist

    2 semanas atrás

    Santo André, São Paulo, Brasil Ansell Tempo inteiro

    About This OpportunityWe are seeking a highly skilled Senior Human Resources Specialist to join our team in Ansell Brasil - Santo André.Role ProfilePosition Title: Senior HR SpecialistJob Location: Ansell Brasil - Santo AndréJob Type: Full-TimeReports to: HR Associate Director LAC RegionKey Responsibilities• Lead human resources responsibility for HR...

  • Regulatory Affairs Specialist

    2 semanas atrás

    Santo André, São Paulo, Brasil Ansell Tempo inteiro

    About this OpportunityWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Santo André, Brazil. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with regulatory requirements for medical devices in Brazil.Key Responsibilities• Preparation and maintenance of regulatory...

  • Sr Specialist

    4 meses atrás

    Santo André, Brasil Ansell Tempo inteiro

    Job Description - Sr Specialist, Resources.Administration (30007012) Job Description Sr Specialist, Resources.Administration-(30007012) Description Why Ansell Ansell is a leading global provider of protection solutions. Our company designs, develops and manufactures a wide range of protection solutions that meet the ever-changing needs and...

  • Regulatory Affairs Specialist

    3 semanas atrás

    Santo André, São Paulo, Brasil Ansell Tempo inteiro

    About AnsellAnsell is a leading global provider of protection solutions, designing, developing, and manufacturing a wide range of protection solutions that meet the ever-changing needs and demands of our markets and industries.Why We Do ItWe believe in protecting people and the planet through innovation and sustainability. Our purpose is protection, and...

  • Regulatory Affairs Specialist

    Há 1 mês

    Santo André, São Paulo, Brasil Ansell Tempo inteiro

    About AnsellAnsell is a leading global provider of protection solutions, designing, developing, and manufacturing a wide range of protection solutions that meet the ever-changing needs and demands of our markets and industries.Our PurposeAt Ansell, our purpose is protection. We believe in protecting people and the planet through innovation and...

  • Performance Monitoring Specialist

    Há 5 dias

    Espírito Santo, Brasil EDP Energias de Portugal S.A. Tempo inteiro

    Job Title:Performance Monitoring SpecialistAbout the Role:We are seeking a highly skilled Performance Monitoring Specialist to join our team at EDP Energias de Portugal S.A. The ideal candidate will have a strong background in performance monitoring and analysis, with experience in developing and implementing performance indicators to detect and resolve...

  • Process Specialist

    4 semanas atrás

    Vitória de Santo Antão, Pernambuco, Brasil Mondelez International Tempo inteiro

    About This RoleWe are seeking a highly skilled Process Specialist to join our team at Mondelez International. As a key member of our Global Business Services team, you will play a critical role in driving process excellence and delivering exceptional service to our customers.Key Responsibilities:Develop and implement process improvements to enhance service...

  • Administrative Specialist

    Há 6 dias

    Santo Amaro, Bahia, Brasil Sandoz Tempo inteiro

    **Administrative Role Overview**We are seeking a highly organized and detail-oriented individual to fill the role of Administrative Specialist. As a key member of our team, you will be responsible for providing general administrative support, including maintaining administrative processes, interacting with team members and external associates, and handling...

  • Bakery Specialist

    2 semanas atrás

    Santo André, São Paulo, Brasil GPA Tempo inteiro

    Descrição do CargoO Padeiro(a) é responsável por elaborar produtos da padaria, seguindo normas de higiene e segurança. Dentre as responsabilidades, incluem-se:ResponsabilidadesElaborar produtos da padaria, garantindo a qualidade e a segurança dos mesmos;Treinar e auxiliar a equipe da produção de pães;Realizar a programação de compras de insumos e...

  • Bakery Specialist

    2 semanas atrás

    Santo André, São Paulo, Brasil Abuellita Cafeteria Tempo inteiro

    Descrição do Cargo: Buscamos um profissional qualificado para atuar na nossa confeitaria, responsável pela produção de pães, bolos, doces e sobremesas. Além disso, você será responsável pelo acompanhamento de estoque e atividades rotineiras ligadas à área de confeitaria. Responsabilidades: - Fabricação de pães e massas diversas; - Preparo e...

  • Marketing Specialist

    3 semanas atrás

    Santo André, São Paulo, Brasil Universidade Livre Holistica Casa de Bruxa Tempo inteiro

    Conhecimentos de ferramentas de edição de imagens e vídeosBuscamos um profissional para trabalhar em nossa equipe de marketing, responsável por editar imagens e vídeos para nossas campanhas.Responsabilidades:Editar imagens e vídeos para nossas campanhas;Desenvolver conteúdo visual atraente para nossas redes sociais;Trabalhar em equipe para criar...

  • Bakery Specialist

    3 semanas atrás

    Santo André, São Paulo, Brasil Abuellita Cafeteria Tempo inteiro

    Descrição do Cargo:Buscamos um profissional para atuar na produção de pães, bolos, doces e sobremesas, além de acompanhar o estoque e realizar atividades rotineiras ligadas à área de confeitaria.Responsabilidades:Executar trabalhos de fabricação de pães;Preparar e cozinhar massas diversas;Acompanhar o estoque e realizar atividades rotineiras...

  • Metalworker Specialist

    Há 5 dias

    Santo André, São Paulo, Brasil ABSAFE SERVICE Tempo inteiro

    Descrição da Vaga:Buscamos profissionais responsáveis para formação de equipes nos cargos de serralheiro 1, 2 e 3, onde atuarão na fabricação e liderança. Bem como, na execução de projetos de fabricação e instalação de estruturas e componentes metálicos, soldas, cortes, dobras e montagens de chapas e perfis metálicos, interpretação de...

  • Technical Support Specialist

    2 meses atrás

    Chácara Santo Antônio, Brasil Siemens Gamesa Tempo inteiro

    Job SummarySiemens Gamesa is seeking a highly skilled Technical Support Specialist to join our team. As a Technical Support Specialist, you will be responsible for providing technical support and troubleshooting for our wind turbines.Key ResponsibilitiesAdvanced troubleshooting of direct drive wind turbines through the analysis of remote dataGuiding site...