Regulatory Affairs Specialist

hace 2 meses


Bogotá Cundinamarca, Colombia Johnson & Johnson A tiempo completo

Declaración DE&I

Durante más de 130 años, la diversidad, la equidad y la inclusión (DEI) han sido parte de nuestro tejido cultural en Johnson & Johnson y están integradas en la forma en que hacemos negocios todos los días. Arraigados en Nuestro Credo, los valores de DEI impulsan nuestra búsqueda de crear un mundo más saludable y equitativo. Nuestra fuerza laboral diversa y nuestra cultura de pertenencia aceleran la innovación para resolver los desafíos de atención médica más apremiantes del mundo.

Sabemos que el éxito de nuestro negocio (y nuestra capacidad para ofrecer soluciones significativas) depende de qué tan bien comprendamos y satisfagamos las diversas necesidades de las comunidades a las que servimos. Es por eso por lo que fomentamos una cultura de inclusión y pertenencia donde se valoran todas las perspectivas, habilidades y experiências y nuestra gente puede alcanzar su potencial.

En Johnson & Johnson, todos pertenecemos.

Estamos buscando al mejor talento para la posición Regulatory Affairs Specialist (UDI) que estará localizado en ciudades principales de Colombia.

Propósito: Responsable de ejecutar el proceso de presentación de documentos de aprobación de productos dentro de los requisitos de presentación. Acelera el proceso de aprobación resolviendo los problemas y garantizando el cumplimiento de las normativas e interpretaciones gubernamentales. Responsable de informar sobre UDI para los productos nuevos y establecidos.

Funciones:

- Ejecuta planes adecuados para la presentación de documentos de aprobación de productos a fin de garantizar una aprobación rápida y oportuna de los productos sanitarios y la continuidad del estado de aprobación de los productos sanitarios comercializados. 60%
- Presta apoyo como POC a las partes interesadas internas de acuerdo con las instrucciones de la dirección. 20%
- Participa y representa al departamento en las reuniones del proyecto de acuerdo con las instrucciones de la dirección. 20%

**Qualifications**:
Requerimientos:

- Formación pregrado titulado: Ciencias de la Salud. Farmacéutico, Bio-Ingeniero, Químico, et
- 3-5 años de experiência
- Inglés 80%
- Conocimientos avanzados de MS Office
- Conocimientos y gestión de UDI muy deseables

Experiência, aptitudes y competencias:

- Gran capacidad de organización.
- Capacidad de gestión de proyectos.
- Aprovecha un conocimiento práctico del entorno normativo, incluido el cumplimiento, las leyes, los reglamentos y las directrices actuales y propuestos, para preparar estrategias normativas conformes que estén en consonancia con los objetivos empresariales y de I+D de la empresa, incluida la consideración del entorno normativo global.
- Ejecuta estrategias normativas de conformidad con las leyes, los reglamentos y los requisitos organizativos pertinentes necesarios para obtener y mantener la situación legal en el mercado.
- Demuestra la capacidad de contribuir al desarrollo de planes estratégicos normativos eficaces y orientados a los resultados que estén en consonancia con los objetivos empresariales.
- Es consciente y receptivo a las diferencias culturales entre regiones y países.
- Sirve como experto técnico para proyectos de baja complejidad dentro de la función de trabajo.
- Capacidad de resolución de problemas.



  • Bogotá, Cundinamarca, Colombia Solventum A tiempo completo

    Job Description: Regulatory Affairs Specialist, Colombia (Solventum) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health,...


  • Bogotá, Colombia Solventum A tiempo completo

    **Regulatory Affairs Specialist, Colombia (Solventum)** **3M Health Care is now Solventum** At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material...


  • Bogotá, Bogotá D.E., Colombia Stryker Group A tiempo completo

    **Job Summary:**We are seeking an experienced Regulatory Affairs Specialist to join our Stryker Group team in LATAM. The successful candidate will be responsible for executing regulatory affairs activities, collecting and maintaining files on RAQA intelligence, and identifying the need for new regulatory procedures.**Key Responsibilities:**


  • Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bogota, Colombia. As a key member of our regulatory affairs department, you will be responsible for implementing programs, processes, and policies to support regulatory activities related to product regulatory, CMC regulatory, and scientific writing.Key...


  • Bogotá, Colombia Buscojobs Colombia A tiempo completo

    Regulatory Affairs Coordinator Latam - Distributor Markets Location: Bogotá Core Mission: Implement Regulatory Affairs programs, processes and policies to support regulatory activities related to products in the Latin American distributor markets. Job Responsibilities: Participate in the planning of Regulatory strategies for product submissions. ...

  • Regulatory Affairs Expert

    hace 3 semanas


    Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

    OverviewAt Medtronic, we pioneer healthcare technology to alleviate pain, restore health and extend life. Our team of 90,000+ passionate people experiment, create, build, improve and solve real-world problems.About the RoleThe Regulatory Affairs Specialist will lead regulatory activities for Latin America, ensuring compliance with regional regulations. This...


  • Bogotá, Bogotá D.E., Colombia Coopervision A tiempo completo

    About CoopervisionCoopervision is a leading manufacturer of high-quality contact lenses and eye care products. We are dedicated to delivering innovative solutions that enhance the lives of our customers.Job SummaryWe are seeking an experienced Regulatory Affairs Specialist to join our team in Coopervision. This role will be responsible for ensuring...


  • Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Galderma, a leading dermatology company, is seeking a highly skilled Regulatory Affairs Coordinator to join its team. This role is ideal for individuals passionate about advancing dermatology and making a meaningful impact on consumers' lives.In this position, you will be responsible for implementing regulatory programs, processes, and policies to support...


  • Bogotá, Cundinamarca, Colombia International Flavors & Fragrances A tiempo completo

    Job Summary Senior Regulatory Affairs Specialist. Focused in Product Compliance and advocacy, business and customer support. Accountable to execute regulatory strategy in the Andean Region. Main focal point to the Functional Ingredients Business. Good relationship skills, good food regulatory knowledge (Andean). Participation in Trade Associations....


  • Bogotá, Bogotá D.E., Colombia Abbvie A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Abbvie. In this role, you will develop and execute regulatory strategies in alignment with Global and Affiliate Regulatory colleagues.Main Responsibilities:Provide strategic direction to support the development of compliant and competitive Regulatory programs.Manage...


  • Bogotá, Cundinamarca, Colombia AbbVie A tiempo completo

    **Company Description** **Major Responsibilities**: - Provides strategic direction to support the development of compliant and competitive Regulatory programs; - Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to drive complete and timely information to Health Authorities; - Effectively...


  • Bogotá, Bogotá D.E., Colombia Werfen A tiempo completo

    OverviewJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans, and perform any regulatory activities for products marketed by Werfen.About the Role:Collaborate with RAQA management to drive business objectives.E nsure compliance with RAQA record management...


  • Bogotá, Bogotá D.E., Colombia Coopervision A tiempo completo

    **Job Overview**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at CooperVision. This role will be responsible for ensuring compliance with regulatory requirements for our medical products.Salary: $80,000 - $110,000 per year, depending on experience and location.Job Description:The ideal candidate will have a strong background...

  • Regulatory Affairs Lead

    hace 4 semanas


    Bogotá, Bogotá D.E., Colombia Allergan A tiempo completo

    Job Overview: At Allergan, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for developing and executing regulatory strategies in alignment with global and affiliate regulatory colleagues.Responsibilities:Develop and execute regulatory strategiesRepresent area on global regulatory product teamsLead...


  • Bogotá, Cundinamarca, Colombia CooperVision A tiempo completo

    Carrying out, controlling, and implementing activities related to the company's quality system. Carrying out, controlling, and implementing the regulatory processes applicable to the company's activities and products. Providing support to the RAQA manager in the department's activities. CooperVision is a global leader in the contact lens industry, dedicated...


  • Bogotá, Bogotá D.E., Colombia Werfenlife Sa. A tiempo completo

    Job Description:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfenlife Sa. This is an exciting opportunity for a motivated and experienced professional to support the implementation and execution of regulatory and quality plans.Key Responsibilities:Support RAQA management with a business focus, ensuring compliance with...


  • Bogotá, Cundinamarca, Colombia Zimmer Colombia 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...


  • Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completo

    Medical Device Regulatory Affairs SpecialistWe are seeking a highly skilled Medical Device Regulatory Affairs Specialist to join our team at Medtronic. As a key member of our regulatory affairs department, you will play a crucial role in leading and preparing RA meetings, planning timelines, and registration strategies for medical devices in Latin...


  • Bogotá, Bogotá D.E., Colombia International Flavors & Fragrances A tiempo completo

    About Us:International Flavors & Fragrances is a global leader in taste, scent, and nutrition, offering innovative solutions to our customers worldwide. We value diversity, inclusion, and collaboration, fostering an environment where every employee can thrive.Job Overview:We are seeking an experienced Regulatory Affairs Specialist to join our team in...


  • Bogotá, Bogotá D.E., Colombia Stryker Corporation A tiempo completo

    Stryker Corporation Job OpportunityWe are seeking a Senior Regulatory Affairs Specialist to join our team in Bogota D.C., Colombia.Estimated Salary: $60,000 - $80,000 per annum.About the RoleThis is a full-time position with hybrid work flexibility.The ideal candidate will have 4+ years of experience in regulatory affairs and a strong understanding of...