20 melhores vagas de regulatory specialist para são paulo sp (Contratando agora!)

Regulatory Affairs Specialist
The Cooper Companies —São Paulo, SP
- Tempo integral
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Há 11 dias
Regulatory Affairs Specialist
Teleflex —São Paulo, SP
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Regulatory Affairs Specialist
Essity —São Paulo, SP
- Tempo integral
- Inglês
- Graduação
Há 12 dias
Regulatory Affairs Analyst I
Thermo Fisher Scientific —São Paulo, SP
- Tempo integral
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
LATAM Policy and Regulatory Specialist (Remote)
Crystal Intelligence —São Paulo, SP
- Tempo integral
- Home Office
- Falar em Público
- Inglês
Há 12 dias
OTC Operations Specialist
Société Générale —São Paulo, SP 06454-000
- Gestão
- PMP
- Inglês
Sr Clinical Site Navigator (Senior Start-up Specialist)
Fortrea —São Paulo, SP
- Tempo integral
- Inglês
- Pesquisa
- Liderança
Permits Compliance Specialist, WHS
Amazon Servicos de Varejo do Brasil Ltda. —São Paulo, SP
- Tempo integral
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Pharmacovigilance Regulatory Reporting (Trilingual)
IQVIA —São Paulo, SP
- Tempo integral
- Inglês
- Banco de Dados
- Graduação
- Trabalho remoto
Há 12 dias
Intern, Investigations Diligence and Compliance - Specialist
Kroll —São Paulo, SP
- Tempo integral
- Microsoft Powerpoint
- Microsoft Word
- Gestão
Há 6 dias
Study Start-up Specialist
BeiGene —São Paulo, SP
- Tempo integral
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Contract Negotiation Specialist (North America team)
IQVIA —São Paulo, SP
- Tempo integral
- Inglês
- Pesquisa
- Graduação
- Trabalho remoto
Há 12 dias
Human Resources – Senior Benefits Specialist – LATAM
Bloomberg —São Paulo, SP
- Microsoft Powerpoint
- Gestão
- PMP
NFR Internal Control Specialist
Nubank —São Paulo, SP
- Tempo integral
- Modelo Híbrido
- Gestão
- Inglês
- SQL
- Vale-transporte
Candidatura rápida
Há 4 dias
Specialist, Quality Assurance
Care Access —São Paulo, SP
- Home Office
- Inglês
- Pesquisa
- Habilidades de Apresentação
Candidatura rápida
Head of DX Quality Management and Regulatory Affairs, LAM (IVD - Diagnostics)
Siemens Healthineers —São Paulo, SP
- Tempo integral
- Modelo Híbrido
- Gestão
- Inglês
- Liderança
Há 3 dias
Analista de Pesquisa Clínica Jr
Pfizer —São Paulo, SP
- Tempo integral
- Home Office
- Gestão
- Inglês
- Pesquisa
Há 5 dias
Senior Product Specialist (Vessel Sealing, Hardware and Electrosurgery)
Medtronic —São Paulo, SP
- Tempo integral
- Gestão
- Inglês
- Graduação
Payroll Specialist
Wise Australia Investments —São Paulo, SP
- R$ 6.850 – R$ 9.500 por mês
- Microsoft Excel
- Inglês
- Agile
Controllership Specialist - Global Product Accounting
Nubank —São Paulo, SP
- Tempo integral
- Modelo Híbrido
- Inglês
- Banco de Dados
- SQL
- Vale-transporte
Candidatura rápida
Há 12 dias

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Regulatory Affairs Specialist

The Cooper Companies -
São Paulo, SP

Candidate-se Agora

Detalhes da vaga

Tempo integral
Há 11 dias

Qualificações

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Inglês
Microsoft Office
Garantia de qualidade
Less
Sistemas de qualidade
Manufatura
Habilidade de Comunicação

Descrição completa da vaga

Carrying out, controlling and implementing activities related to the company's quality system.

Carrying out, controlling and implementing the regulatory processes applicable to the company's activities and products.

Providing support to the LATAM RAQA manager in the department's activities.

Responsible for activities related to the Regulatory Affairs and Quality Assurance department.

Knowledge, Skills and Abilities:

Knowledge of quality systems and good manufacturing, storage and distribution practices for medical products;
Availability to work in the office;
Advanced knowledge in Microsoft Office Suite including Word, PowerPoint and Excel - advanced
Good problem-solving, decision-making, organizational, analytical and critical thinking skills
Good written and verbal communication skills and interpersonal relationship skills
Ability to read, write and speak English (advanced) and Spanish (basic);
Solid knowledge and understanding of local and global regulations relevant to medical devices
Solid knowledge and understanding of global regulatory requirements for new products or product changes.
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to build productive internal/external working relationships

Experience:

Minimal of 5 years’ experience in Regulatory Affairs and Quality Assurance, minimum of 02 years in the position. Experience with other Latin American countries would be a plus.

Education:

Graduated in pharmacy or another health area.
Registration with an active professional council.

Essential Functions & Accountabilities:

Prepare and review dossiers for product notification/registration, renewals and/or changes;
Active involvement with new projects and new product developments.
Proper evaluation of technical documents, change controls, dossiers, gap assessments, etc.
Identify trends, assess impact, analyze alternatives and recommend action plans
If necessary, acts as Technical Responsible Person in front of Brazilian authorities
Control and renew the company's operating licenses and permits;
Review and approve marketing and commercial materials.
Provide regional regulatory input during cross functional business projects.
Involvement with local competent authorities and trade associations on an as needed basis.
Responsible for developing the regulatory intelligence plan: monitoring, evaluating and reporting on publications and changes relating to the business.
Support of regional, and as needed global, regulatory demands to the different internal stakeholders.
Prepare, review and monitor procedures for the Quality Management System (RDC nº665/22);
Support quality activities according to demand: product complaints, non-conformities, environmental control, product reception, nationalization, internal audits.
Receive internal and external audits
Assures proper decision making in case of Quality issues
Assure CVB quality system is aligned with ISO 13485 and MDSAP requirements
Responds to corporate inquiries and follow up to internal processes: RAID, PRCO, PCO´s

Travel :

Occasional trips, less than 5% of the time.

Work Environment:

Prolonged sitting in front of a computer

Candidate-se Agora

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