Regulatory Specialist

Há 5 dias


Rio de Janeiro, Brasil BW Energy Tempo inteiro

Define the scope and deadlines for deliverables that sustain compliance with applicable regulatory requirements, observing production schedules and budgets.
- Support the definition of responsibilities and resources to achieve regulatory compliance efficiently, observing the BWE organization charts and budgets.
- Incorporate lessons learned to BWE, set action plans to prevent or address audit findings, notifications, and conditions to operate imposed by the Authorities.
- Collaborate with engineering, sustainability, safety, project management, and operations to ensure awareness of regulatory requirements, build compliance, and fulfill BWE schedules.
- Ensure that compliance-related tasks are executed efficiently, facilitating licenses and approvals, as well as preventing fines and interdictions.
- Consolidate engineering document lists, including all tech safety studies that are required to grant and sustain licenses and approvals needed to operate.
- Assess the content of engineering, tech safety, and other management system documents to provide proper support and guidance to achieve compliance.
- Follow up on specific discussions and execution wherever assigned to ensure proper incorporation of regulatory compliance requirements and related risk.
- Coordinate activities to implement BWE strategy and scope for internal regulatory compliance self-assessment, inspections, and audits to prevent project schedule delays, interdictions and fines.
- Track, manage, and ensure proper closure and documentation of regulatory-related action items.
- Perform and/or guide inspections and audits of BWE facilities to assess and ensure proper compliance with regulatory and statutory requirements.
- Organize and coordinate internal preparations for regulatory audits.
- Flag to the Regulatory and Institutional Affairs Manager always when a potential critical non-conformance is identified or delays in regulatory compliance may delay schedules or not follow the original budgets.
- Support all other regulatory-related activities when required.

**Requirements**:
**Education**
- Engineering background;
- Relevant experience on ANP Management System Safety audits and Offshore Projects; Relevant knowledge on Environmental Licensing, Flag, Class, Navy, ANVISA, ANAC, and other requirements for offshore projects;
**Experience**
- Minimum 5+ years of experience in Regulatory requirements applied to offshore platforms.
- Experience in fulfilling requirements for ANP shipyard audits.
- Experience in answering ANP conditions to operate Class, Flag, Navy basic understanding

**Knowledge**
- Good understanding and knowledge of Offshore systems
- Familiar with engineering/industry standards such as API, ASME, ASTM, NACE etc Fluent in English and Portuguese (oral and written).
- **Other**
- Some travel required
- Location: To be defined, Brazil



  • Rio de Janeiro, Rio de Janeiro, Brasil Alimentiv Tempo inteiro

    Overview Regulatory Affairs Specialist (LATAM) responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and...


  • Rio de Janeiro, Brasil bioMérieux Tempo inteiro

    A family-owned company, bioMérieux has grown to become **a world leader in the field of in vitro diagnostics**. For almost 60 years and across the world, we have imagined and developed **innovative diagnostics solutions** to **improve public health**. Today, our teams are spread across 45 countries and serve 160 countries with the support of a large...


  • Rio de Janeiro, Brasil BW Energy Tempo inteiro

    Ensure that the BWE process of regulatory compliance assessment and monitoring is in place. - Ensure that all operational-related contractors and BWE operations in Brazil are recurrently assessed and monitored regarding regulatory requirements. - Ensure that all activities, for which is under this one responsible, are carried out in conformance with laws and...

  • Regulatory Data Specialist

    3 semanas atrás


    Região Geográfica Intermediária de Sorocaba, Brasil Louise Domingues Tempo inteiro

    Regulatory Data Specialist (Mid-Level) – Remote We are building the first global digital regulatory infrastructure, powered by AI, connecting regulators and companies in 20+ countries.If you love data, innovation, and technology, and want to grow with a fast-scaling startup, this role is for you.Location: RemoteContract: Full-time | PermanentWhat you will...

  • Medical, Regulatory

    Há 7 dias


    Rio Grande do Sul, Brasil Novo Nordisk Tempo inteiro

    Medical, Regulatory & PV Specialist**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Podgorica, Podgorica, RS**The Position**- As a Medical, Regulatory and Pharmacovigilance Specialist at Novo Nordisk, you will secure timely safety reporting in compliance with relevant requirements and maintain the pharmacovigilance (PV) system. You will...

  • Senior Regulatory Specialist

    2 semanas atrás


    Rio De Janeiro, Brasil Fortrea Tempo inteiro

    Job Overview: Primary contact with investigative site(s) during site start-up activities and maintenance with responsibility for collection of the required investigator and essential documents for a study, to ensure EC/IRB/Third body/Regulatory Authority and any other local applications are made within the timelines agreed with project management and Site...


  • Rio de Janeiro, Brasil beBeeCompliance Tempo inteiro

    Job Overview Our Senior Regulatory Specialist will be the primary contact with investigative sites during site start-up activities and maintenance. They will be responsible for collecting the required investigator and essential documents to ensure timely submission to EC/IRB/Third body/Regulatory Authority and that documentation meets applicable regulations...

  • Field Specialist Trainee

    2 semanas atrás


    Rio De Janeiro, Brasil Schlumberger Tempo inteiro

    The Field Specialist Trainee is responsible for maintaining safe, efficient, and reliable PSD to Customers. The Field Specialist Trainee identifies opportunities to improve service delivery, implements standard work, and manage, risk during service delivery. - Ensure job deliverables are accurate and delivered on time. - Responsible for service delivery...


  • Rio de Janeiro, Brasil Mexico Tempo inteiro

    **ALL CV´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED!** **Essential Functions**: - Assist/Advise project teams on all regulatory requirements for clinical studies - Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings - Review and adapt study specific...


  • Rio de Janeiro, Brasil Mexico Tempo inteiro

    **ALL CV´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED!****Essential Functions**:- Assist/Advise project teams on all regulatory requirements for clinical studies- Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings- Review and adapt study specific...