Regulatory Affairs Officer

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...

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...

Job DescriptionWe are seeking an experienced and self-motivated **Regulatory Officer (Telecom)** to join our global legal and regulatory team. This pivotal individual contributor role will allow you to independently manage complex regulatory matters, with an initial priority on the Latin-American (LATAM) region while supporting broader international...

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...

Elaborar e submeter processos de registro, pós registro de medicamentos, produtos para saúde ou cosméticos, incluindo levantamentos, elaboração de justificativas técnicas, discussões, trocas e alinhamentos com as áreas envolvidas (matriz, indústria, clínica, médica, etc); - Elaborar os processos de alteração/notificação de textos de bula e...

Rio de Janeiro, Brazil- Full-time- Technical and Functional Expertise- Hybrid- Tietoevry Create**Job Description**:We are seeking an experienced and self-motivated **Regulatory Officer (Telecom)** to join our global legal and regulatory team. This pivotal individual contributor role will allow you to independently manage complex regulatory matters, with an...

Rio de Janeiro, Brazil - Full-time - Technical and Functional Expertise - Hybrid - Tietoevry Create **Job Description**: We are seeking an experienced and self-motivated **Regulatory Officer (Telecom)** to join our global legal and regulatory team. This pivotal individual contributor role will allow you to independently manage complex regulatory matters,...

Key Responsibilities: Maintain regulatory awareness, ensuring up-to-date knowledge of applicable laws and guidelines. Coordinate the collection and organization of data and information required by regulatory authorities, including the preparation of study documentation such as country application forms and cover letters.

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...

**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...