Regulatory Affairs Specialist

hace 2 días


Bogota, Colombia bioMérieux sa A tiempo completo

Propósito Primario y objetivo General del Puesto:
Asegurar la implementación y la conformidad a leyes y regulaciones vigentes establecidas por agencia regulatoria local (INVIMA), los estándares del FDA y la directiva de la comunidad europea para la importación, comercialización, distribución de productos para diagnostico in vitro y control microbiológico.
2 Principales **Responsabilidades**:
Realizar los trámites necesarios antes el INVIMA y las entidades regulatorias nacionales a fin de mantener actualizados los registros sanitarios, certificados No requiere y las autorizaciones de funcionamiento necesarias bajo la normativa vigente para mantener disponible la oferta de productos.
Determinar el estado de cumplimiento de la normativa de la autoridad sanitaria local, lineamientos corporativos, estándares de la FDA y directrices de la comunidad europea
Asegurar el cumplimiento de la normativa local en relación a la mejora o cambios de productos comunicados por RA corporativo
Seguimiento de programa de Reactivo-Vigilancia y Tecno-Vigilancia ante la autoridad sanitaria local y de acuerdo a las directrices corporativas
Cumplir todas las funciones descritas en la Resolución 132 de 2006 y la Resolución 4002 de 2007 como Director Técnico.
Participar y contribuir al cumplimiento de los objetivos del Sistema de Gestión de la Seguridad y Salud en el Trabajo SG-SST de bioMérieux Colombia.
3 Estudios Típicos
- Experiência, Habilidades y Calificaciones:
3.1 Estudios-Experiências:

- Químico Farmacéutico/Bacteriólogo/Microbiólogo
- 5 años de experiência en asuntos regulatorios de industrias IVD/MD

3.2 Habilidades y Calificaciones:

- Conocimiento de las regulaciones colombianas aplicables para reactivos de IVD de control microbiológico y dispositivos médicos
- Conocimiento de la legislación internacional aplicable (QSR/ISO/FDA/CSA)

4 Alcance y Recursos, Indicadores Típicos de Desempeño - Scope and Resources Accountability, Typical Performance Indicators:

- Alcance y responsabilidad de recursos: Todos los productos (Reactivos de IVD, control microbiológico e instrumentos)
- Indicadores financieros (revenue, budget, etc.): N/A
- Key Performance Indicators (KPIs): Respuestas ante entes regulatorios oportunas/RA KPI Performance
- Key Contacts (internos/externos) e Interfases: todos los procesos/INVIMA/Clientes/Proveedores



  • Bogota, Colombia ARIAD A tiempo completo

    **REGULATORY AFFAIRS SPECIALIST**: Bogotá, Bogota D.C. **Job ID** R0117127 **Category** Research & Development **Subcategory** Research & Development **Business Unit** Global Portfolio Division **Job Type** Full time **Regulatory Affairs Specialist** **_ Versión Español_** **PROPOSITO DEL ROL** Este rol es responsable de apoyar el plan...


  • 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...


  • Bogota, Colombia Takeda Pharmaceutical A tiempo completo

    **Regulatory Affairs Specialist** **_ Versión Español_** **PROPOSITO DEL ROL** Este rol es responsable de apoyar el plan estratégico del negocio para obtener autorizaciones de comercialización y variaciones, tanto para productos existentes como nuevos. Además, coordinará las actividades de Excelencia Regulatoria en Colombia asegurando el...


  • 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...


  • 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...


  • Bogota, Colombia Zimmer Biomet A tiempo completo

    At 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...


  • Bogota, Colombia MSD A tiempo completo

    **Job Description**: **Objetivo del cargo Regulatory Affairs Specialist Animal Health**: Respaldar al Director Científico en su actuación ante el Instituto Colombiano Agropecuario en Colombia, con el fin de asegurar el cumplimiento de las regulaciones regionales por parte de la operación de la compania en el país. Colaborar en el proceso de registro para...


  • Bogota, Colombia Novasyte A tiempo completo

    POSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & Johnson Vision, a member of Johnson and Johnson's Family of Companies, is recruiting for a Regulatory Affairs Specialist located preferably in Colombia, or Mexico. An exciting opportunity to join a diverse team. At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating...


  • Bogota, Colombia AbbVie A tiempo completo

    **Company Description** - Preparation of state-of-the-art regulatory dossiers, according to product regulatory strategy previously aligned. - T end to look always for a first pass approval from the health authorities. In case any inquire, assure a timely and accurate response as well as look for learning, avoiding same inquiries in future regulatory...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    At 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 130...


  • Bogota, Colombia ABBVIE A tiempo completo

    Join us at AbbVie, where medicine, aesthetics, and science are powered by some of the brightest minds in the world. We're a dynamic biopharmaceutical company that offers you the resources you need and a global reach that empowers your innovative mindset. From day one, we've known it takes teamwork, passsion, and culture built on diversity and inclusion to...


  • Bogota, Colombia Lilly A tiempo completo

    At 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...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & 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...


  • Bogota, Colombia Johnson & Johnson A tiempo completo

    At **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...

  • 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...


  • Bogota, Colombia Galderma A tiempo completo

    With 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...


  • 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...


  • Bogota, Colombia Zimmer Biomet A tiempo completo

    At 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...