![B Braun](https://media.trabajo.org/img/noimg.jpg)
Regulatory Affairs and Post market Surveillance
hace 4 semanas
**Descripción empresa**:
TRABAJAMOS CADA DÍA PARA SER UN PROVEEDOR COMPLETO PARA EL CUIDADO DE LA SALUD.
En B. Braun desarrollamos soluciones eficientes y buenas prácticas para el cuidado de la salud gracias a un diálogo constructivo con nuestros clientes y colaboradores.
A través de una estrecha relación y cooperación con los profesionales de la salud combinamos nuestros servicios y productos para ofrecer soluciones inteligentes y eficientes que cubran terapias completas y nos permitan seguir creciendo juntos.
**Misión del cargo**:
Garantizar el cumplimiento de las actividades referentes a la radicación de expedientes de registros sanitarios presentados ante el INVIMA,
**Funciones del cargo**:
Solicitar en conjunto con el líder del departamento los documentos requeridos para realizar los trámites propios del área como la renovaciones, modificación y nuevos registros sanitarios
Elaboración de expedientes para las solicitudes de los registros sanitarios de medicamentos, dispositivos médicos, cosméticos, alimentos regulares y alimentos con propósitos médicos especiales APME bajo la coordinación del líder del departamento.
Solicitar la traducción a la empresa autorizada de los documentos técnicos y legales seleccionados para la elaboración de los expedientes.
Preparar y radicar las solicitudes de registros y presentarlas en el aplicativo establecidos por el INVIMA.
Dar respuestas a los autos emitidos por el INVIMA, bajo la coordinación por parte del líder del departamento y hacer seguimiento al trámite.
Asegurar mitigar el riesgo de cancelación y/o suspensión de registros sanitarios asegurando las acciones para evitar poner en riesgo la venta de los productos de la compañía.
Verificar constantemente el correo de asuntos regulatorios donde el INVIMA notifica los actos administrativos de los tramites relacionado con la compañía.
Organizar y garantizar el correcto archivo de los expedientes de los productos radicados ante INVIMA.
Elaborar y presentar al líder inmediato los informes del estado de trámites ante INVIMA.
Elaborar las fichas técnicas y hojas de productos (que apliquen) de los productos registrados y comercializados por BBMCO, para la aprobación por parte del líder del departamento.
Creación, modificación de los documentos en SAP de los materiales relacionados con los registros sanitarios (COI), clientes autorizados para comercializar medicamentos de control especial (COC), venta de medicamentos de BBMCO (COF), previa delegación y autorización del líder del departamento.
Actualización de la información de registros y demás documentos en las bases de datos de asuntos regulatorios cada vez que se expida algún trámite al departamento.
**Requisitos**:
Experiência mínima de 1 año en el área de Asuntos Regulatorios
Profesional en Química Farmacéutica, Ingeniería Biomédica.
2 años de experiência manejando el programa de Vigilancia Post Mercado.
**Condiciones oferta**:
-
Post Market Surveillance Specialist
hace 2 semanas
Bogota, Colombia Zimmer Biomet A tiempo completo**Requisition Number**: AMER27850 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: The Post Market Surveillance Specialist is document owner for Post Market Surveillance Activities; will document PMS Plans and, if the case, PMS Reviews (PSURs or PMSRs) records according to the applicable regulations (including MDR (EU) 2017/745); he...
-
Post Market Surveillance Specialist
hace 2 semanas
Bogota, Colombia Zimmer Biomet A tiempo completo-Requisition Number AMER27850 Employment Type Full-time Location Bogota **Job Summary**: - The Post Market Surveillance Specialist is document owner for Post Market Surveillance Activities; will document PMS Plans and, if the case, PMS Reviews (PSURs or PMSRs) records according to the applicable regulations (including MDR (EU) 2017/745); he /she will be...
-
Post Market Surveillance Specialist, Gbs
hace 4 semanas
Bogota, Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...
-
Post Market Surveillance Specialist, Gbs
hace 4 semanas
Bogota, Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...
-
Post Market Surveillance Specialist, Gbs
hace 3 semanas
Bogota, Colombia Zimmer Colombia A tiempo completoAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...
-
Regulatory Affairs
hace 4 semanas
Bogota, Colombia B. Braun Medical S.A. A tiempo completoGarantizar el cumplimiento de las actividades planeadas referentes a la radicación de los expedientes de registros sanitarios presentados ante el INVIMA, de acuerdo con la programación del Departamento de Asuntos Regulatorios, asesoría técnica a los departamentos de la compañía que lo requieran, asegurando que todos los productos bajo su...
-
Manager, Regulatory Affairs
hace 2 semanas
Bogota, Colombia Johnson & Johnson A tiempo completoAt **Johnson & Johnson **, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than...
-
Regulatory Affairs Manager
hace 6 días
Bogota, Colombia Lilly A tiempo completoAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
-
Regulatory Affairs Specialist
hace 3 semanas
Bogota, Colombia Zimmer Biomet A tiempo completo**Requisition Number**: AMER28216 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission...
-
Latam Regulatory Affairs Leader Medtech
hace 2 meses
Bogota, Colombia Johnson & Johnson A tiempo completoJohnson & Johnson MedTech is one of three successful divisions of the world's leading Johnson & Johnson family of companies. We are making an important contribution to the successful treatment of a wide range of common and chronic diseases with innovative - often pioneering - medical technologies and products. Are you ready to take your regulatory affairs...
-
Regulatory Affairs Specialist
hace 4 semanas
Bogota, Colombia Zimmer Biomet A tiempo completoAt Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...
-
Medical Writer
hace 2 semanas
Bogota, Colombia Zimmer Biomet A tiempo completo**Requisition Number**: AMER27845 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: The Medical Writer is primarily responsible for preparing Clinical Evaluation Reports (CERs) for regulatory submissions and Post-market Surveillance Plan literature reviews (PSPs) for analysis of existing product clinical performance. Both involve...
-
Medical Writer
hace 2 semanas
Bogota, Colombia Zimmer Biomet A tiempo completo-Requisition Number AMER27845 Employment Type Full-time Location Bogota **Job Summary**: - The Medical Writer is primarily responsible for preparing Clinical Evaluation Reports (CERs) for regulatory submissions and Post-market Surveillance Plan literature reviews (PSPs) for analysis of existing product clinical performance. Both involve conducting searches...
-
Regulatory Affairs Specialist
hace 3 semanas
Bogota, Colombia Medtronic A tiempo completo**Careers that Change Lives** **A Day in the Life** Responsibilities may include the following and other duties may be assigned. - Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. - Leads or compiles all materials required in submissions, license...
-
Regulatory Affairs Manager Ch Andean
hace 4 semanas
Bogota, Colombia Bayer A tiempo completo**Regulatory Affairs Manager CH Andean** When you show proactivity and ambition, we’ll harness it through a variety of opportunities and challenges in the diverse areas of our business - all with a strong and meaningful purpose. Where do you want to go? What do you want to do? How do you want to maake a difference? The choice is yours, and we’ll help...
-
Regulatory Affairs Analyst
hace 4 semanas
Bogota, Colombia Galderma A tiempo completoWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
-
Regulatory Affairs Analyst
hace 24 horas
Bogota, Colombia Galderma A tiempo completoWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...
-
Senior Regulatory Affairs Specialist
hace 3 semanas
Bogota, Colombia Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with...
-
Intern Regulatory Affairs
hace 3 semanas
Bogota, Colombia Zimmer Biomet A tiempo completo**Requisition Number**: AMER29097 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: The Regulatory Affairs Department of ZB plays a critical role in ensuring that our products comply with all regulations and requirements established by regulatory authorities. This department is responsible for coordinating and managing all activities...
-
Intern Regulatory Affairs
hace 3 semanas
Bogota, Colombia Zimmer Biomet A tiempo completo-Requisition Number AMER29097 Employment Type Full-time Location Bogota **Job Summary**: - The Regulatory Affairs Department of ZB plays a critical role in ensuring that our products comply with all regulations and requirements established by regulatory authorities. This department is responsible for coordinating and managing all activities related to the...