Clinical Monitor and Regulatory Affairs Researcher

Há 5 dias

Campinas, Brasil Samsung Electronics Tempo inteiro

Position Summary

1. Share clinical knowledge with researchers and projects stakeholders and collaborate with external partners/customers in the planning and execution of innovative commercial and clinical research projects.

2. Contribute to the health data analysis and decision-making process in collaboration with internal teams.

3. Conduct designing of clinical trial protocols comprising medical and non-medical wearable devices for health, wellness and fitness purposes.

4. Support Regulatory related activities: Submission and follow-up of research projects to regulatory entities and risk assessment of current and new projects from regulatory and data management standpoints.

Role and Responsibilities

Key responsibilities

Coordinate all activities relating to regulatory compliance and the submission of specified documentation;

Prepares and submits regulatory report/process for FDA and ANVISA;

Working knowledge of current devices regulation;

Ensures compliance with regulatory agency regulations and interpretations;

Prepares responses to regulatory agencies questions and other correspondence;

Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines;

Involved with the preparation of necessary for necessary outlines, summaries, status reports, graphs and slides;

Provides solution to a variety of problems of moderate scope and complexity;

Provide regulatory affair support during internal and external audits;

Knowledge of Federal Regulations;

Demonstrated written and verbal communication skill;

Strong time management skills, with the ability to work on multiple projects simultaneously;

Ability to work independently as well as within a team;

Excellent medical devices written and verbal communication skills in English and Portuguese;

Manage projects;

Ability to organize and prioritize workflow;

Achieved regulatory approvals for Medical devices;

Enthusiastic of Artificial Intelligence for health.

Skills and Qualifications

PhD and/or MSc: Regulatory Affair, Medical Sciences, Biomedical Sciences, Biology, Pharmacy, Engineer, or the equivalent combination of the education and experience obtained from a university with solid professional experience.

Experience in FDA/CEP/CONEP regulated, Medical Device and/or Scientific Experience.

**Language**:
Written and verbal fluency in Portuguese and English.

City: Campinas
- Confidential and proprietary information obtained by you during your employment history in other companies must be maintained as such (confidential & proprietary) throughout the selection process, not in any event, be opened or shared with the interviewers._

  • Health Research

    Há 5 dias

    Campinas, Brasil Samsung Electronics Tempo inteiro

    Position Summary 1. Share clinical knowledge with researchers and projects stakeholders and collaborate with external partners/customers in the planning and execution of innovative commercial and clinical research projects. 2. Contribute to the health data analysis and decision-making process in collaboration with internal teams. 3. Conduct designing of...

  • R&d Clinical Analyst

    1 dia atrás

    Campinas, Brasil Zoetis Tempo inteiro

    locations- Campinas- time type- Full time- posted on- Posted Today- job requisition id- JR00013405- Role Description - Responsible for supporting research & development clinical studies for pharmaceutical (antiparasiticides) projects in compliance with appropriate regulatory requirements and internal policies. Effectively collaborates with the...

  • Regulatory Compliance Analyst

    2 semanas atrás

    Campinas, Brasil Hedgepoint Group Tempo inteiro

    Job Purpose The Regulatory Compliance Analyst supports global compliance efforts by executing risk assessments, monitoring regulatory changes, maintaining internal controls, and contributing to training and cross-functional collaboration. The role ensures that Hedgepoint operates in full compliance with applicable laws, financial market regulations, and...

  • Regulatory Compliance Analyst

    2 semanas atrás

    Campinas, Brasil Hedgepoint Global Markets Tempo inteiro

    Overview The Regulatory Compliance Analyst supports global compliance efforts by executing risk assessments, monitoring regulatory changes, maintaining internal controls, and contributing to training and cross-functional collaboration. The role ensures that Hedgepoint operates in full compliance with applicable laws, financial market regulations, and...

  • Clinical Talent Acquisition Specialist

    Há 7 dias

    Campinas, Brasil Bebeeclinicaltalentacquisition Tempo inteiro

    Job DescriptionWe are seeking a highly skilled Clinical Talent Acquisition Specialist to join our team.As a key member of our organization, you will be responsible for leading full-cycle recruiting across various teams.The successful candidate will work closely with Operations and Study Start-Up to anticipate demand and build pipelines that enable quick site...

  • Field Researcher

    2 semanas atrás

    Campinas, São Paulo, Brasil Gowan Tempo inteiro R$40.000 - R$60.000 por ano

    Position Summary:The field researcher is responsible for the execution of the biological efficacy evaluation program for Gowan products at the experimental field station located in Artur Nogueira, São Paulo, Brazil.Job Status:Full-TimeSalaried / CLTWorkplace: Artur Nogueira, São Paulo, BrazilReports to: LATAM Development ManagerRelationship: Brazil...

  • Field Researcher

    2 semanas atrás

    Campinas, Brasil Gowan USA Tempo inteiro

    **Position Summary**: - The field researcher is responsible for the execution of the biological efficacy evaluation program for Gowan products at the experimental field station located in Artur Nogueira, São Paulo, Brazil. **Job Status**: - Full-Time - Salaried / CLT - Workplace: Artur Nogueira, São Paulo, Brazil - Reports to: LATAM Development...

  • Field Researcher

    2 semanas atrás

    Campinas, Brasil The Gowan Co. Tempo inteiro

    **Position Summary**: **The field researcher is responsible for the execution of the biological efficacy evaluation program for Gowan products at the experimental field station located in Artur Nogueira, São Paulo, Brazil. **Job Status**: - Full-Time - Salaried / CLT - Workplace: Artur Nogueira, São Paulo, Brazil - Reports to: LATAM Development Manager -...

  • Pesquisador pleno | researcher

    2 semanas atrás

    Campinas, Brasil Netvagas Tempo inteiro

    Doutorado em Física, Química, Ciência dos Materiais ou áreas relacionadas;Experiência em difração coerente de raios X, ptycografia, tomografia, SAXS;Experiência com instrumentação de linha de luz;Experiência com programação (pyhon, matlab), análise de dados e tratamento de imagens, avizo, imageJ;Inglês

  • Senior Onboarding and Compliance Processes

    1 semana atrás

    Campinas, São Paulo, Brasil Hedgepoint Global Markets Tempo inteiro R$80.000 - R$150.000 por ano

    PURPOSE OF POSITION:Analyst will optimize client and partner onboarding by designing, maintaining, and enhancing workflows and digital solutions. Leveraging data analysis and business intelligence tools, this role will streamline registration processes while ensuring strict compliance with applicable laws and regulations.CORE COMPETENCES:Onboarding...