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Descrição da vaga:
- Provide advice and guidance to global product teams to ensure regulatory submissions meet Brazil laws and regulations for both medical devices and pharmaceuticals products.
Provide guidance and training to RA Analyst personnel on planning, preparation, processes, and timelines for regulatory submissions.
Develop efficient and cost-effective processes that meet all requirements, which includes; timely registration of new products, renewals, modifications, and transfer of product licenses.
Identifying potential risks to the submission timelines or strategies.
Driving timelines and deliverables related to submission documents.
Present all updates and renewals of all products being currently commercialized, to the local Health Governmental Organization.
Reviews and approves product labeling and advertising material per Brazil Labeling requirements.
Serves as primary liaison with Brazil regulatory agencies (ANVISA and all other regulatory agencies). This includes:
Manage and prepare responses to inquire as issued by ANVISA or any other Regulatory Agency.
Assist with determining, reviewing, and tracking of complaints.
Manages and assists in departmental budget to ensure planning and spending is consistent with established RA expense goals.
Coordinate and assists in regulatory and certification inspections as well as all communication with regulatory officials and other certification agencies.
Coordinate and provide technical guidance during internal audit activities.
Manage RA internal audits, which includes, review of all Health Licenses, to ensure compliance with Brazilian Regulations and in line with Brazilian Operations.
Monitor and ensure that Health Licenses are updated.
Determines the need for RA contract services (both vendors and temporary staff) as well as the expertise required.
Supervise Regulatory Affairs Analyst and/or RA/QA personnel.
Develop training materials and providing training to internal RA personnel where appropriate.
Participate in conference calls with peers at manufacturing sites to discuss product registration priorities and timelines to ensure all are in agreement and on-time.
Responsible for the development, implementation and monitoring of all quality procedures.
Responsible for Implement an effective quality system in order to obtain certification of the GMP ? Good Manufacturing Practises: implementation and training of each POP,
Supplier/Qualification, Self-Inspection
Request certification ANVISA
Make sure Gambro complies with all regulatory and quality legislation
- Experience in the Quality Assurance area.
- Bachelor of Pharmacy.
- The candidate must have a solid knowledge on all regulatory process regarding Medical Device and Pharmaceuticals Management in Brazil. Knowledge in Global regulation is plus. In addition, must have a business and international mindset, someone who thrives in a dynamic environment. It is imperative that the candidate is a team player and able to communicate and work with employees of diverse culture.
Strong management skills.
Strong communications and teamwork skills.
Ability to multitask and switch gears quickly.
Exercise of independent judgment in the performance of assigned duties.
Exhibits a high degree of integrity, initiative and motivation.
Analytical capacity.
Capability to work and deliver results under stressful conditions.
- Benefícios: Assistência Odontológica, Carro fornecido pela empresa, Celular fornecido pela empresa, Combustível, Convênio com farmácia, Estacionamento, Participação nos lucros, Previdência privada, Seguro de vida em grupo, Seguro saúde, Tíquete-refeição
- Regime de contratação: CLT (Efetivo)
- Horário: Commercial.
- Informações adicionais: Fluent in Spanish will be a plus.
Idiomas:
Inglês - Fluente, Espanhol - Intermediário
Área profissional:
- Industrial
- Jurídica
- Médico/ Hospitalar
- Qualidade
Nível hierárquico:
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Descrição da empresa:
- Comércio de equipamentos médicos.
Nacionalidade / Porte da Empresa:
- Multinacional de médio porte com 50 funcionários
Site da empresa:
Ramo da empresa:
- Equipamentos médicos / precisão
Serviços e produtos:
- Equipamentos e acessórios médicos, dentários e hospitalares.
- Serviços comerciais, sem outra classificação.
Qualificações da empresa:
- Anuncia vagas na Catho há 1 ano e 1 mes.
- Anunciou 7 vagas nos útimos 12 meses.
- Já contratou candidatos para outras vagas anunciadas na Catho.
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