Regulatory Affairs Specialist
hace 2 semanas
**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 process in different regions such as Asia Pacific, Latin America and EMEA
**Principal Duties and Responsibilities**: -Preparation, assembly, storage, tracking and retrieval of information pertinent to the regulatory processes, including the regulatory submissions process. May author and publish electronic submissions for product registrations, renewals and registration changes.
- Maintains registration databases, product registration records, key performance indicators current, and communicates approved registrations.
- Executes registration processes in assigned countries, working closely with Business Unit Regulatory Teams to request information, business partners “distributors” to ensure registrations are submitted on time and kept current in compliance with applicable legislation.
- Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
- Evaluate risk of proposed regulatory strategies; may offer solutions
- Reviews proposed labeling and package inserts for compliance with applicable regional regulations
- Respond to requests for additional information from foreign governments
- Reviews proposed product changes for impact on regulatory status of the product
- Supports the creation of Technical documentation files in the Regulatory Information Management System
- Applies regulations to business practices and provides regulatory input, advice and guidance to cross-functional teams
**Expected Areas of Competence**: -Strong writing, communication, and interpersonal skills
- Strong attention to detail; ability to multi-task and balance competing priorities
- Knowledge of overall business environment, the orthopaedic industry, and the marketplace
- Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
- Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
- Knowledge of regulations in at least one of the following regions: LATAM, APAC, and EMEA.
- Ability to identify risk in Regulatory strategies
- Strong problem solving skills
- Effective negotiating skills
- Basic computer skills, including Microsoft Office Suite
**Education/Experience Requirements**: -Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
- English Proficiency is required.
- A minimum of one year of experience in orthopedic or medical device industry preferred
- A minimum of 3-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
- Regulatory Affairs Certification (US, EU, or Global) preferred
- A combination of education and experience may be considered
**Travel Requirements**: 10%
-
Regulatory Affairs Specialist
hace 1 semana
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...
-
Regulatory Affairs Specialist
hace 1 semana
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 Process Specialist
hace 2 semanas
Bogota, Colombia Johnson & Johnson A tiempo completo**Regulatory affairs specialist**: At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for 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...
-
Regulatory Affairs Specialist
hace 2 semanas
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...
-
Regulatory Affairs Specialist
hace 1 semana
Bogota, Colombia MSD A tiempo completoObjetivo 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 MSD AH en el país. Colaborar en el proceso de registro para asegurar la aprobación y/o...
-
Regulatory Affairs Specialist
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 130...
-
Regulatory Affairs Specialist
hace 1 semana
Bogota, Colombia MSD A tiempo completoThis role will strategically execute the regulatory road map for our portfolio and pipeline to support company success and growth, by creating the greatest value for patients and in turn all stakeholders. Ensure compliance with local legislations to achieve the regulatory objectives, provide advisory and support to key stakeholders such as marketing,...
-
Intern Regulatory Affairs
hace 1 semana
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 1 semana
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...
-
Associate Manager Regulatory Affairs
hace 1 semana
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 130...
-
Sr Reg Affairs Spec
hace 3 semanas
Bogota, Colombia Thermo Fisher Scientific A tiempo completoJob Description 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 regulatory affairs responsibilities, leading...
-
Sr Associate Regulatory Affairs
hace 2 semanas
Bogota, Colombia Amgen A tiempo completoHOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...
-
Practicante - Regulatory Affairs
hace 1 semana
Bogota, Colombia Genfar A tiempo completo**Descripción de la empresa** **_ Elijo Cuidarme, Yo Elijo Genfar_** El lograr una vida plena y saludable es posible. En Genfar, esto se logra a través de su gente; personas con distintas nacionalidades, roles, conocimientos y creencias que luchan constantemente para llevar lo mejor del mundo de la salud, a toda la sociedad con los más altos estándares...
-
Associate Regulatory Affairs
hace 3 semanas
Bogota, Colombia Amgen A tiempo completo**HOW MIGHT YOU DEFY IMAGINATION?**: If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...
-
Compliance and Regulatory Affairs Specialist
hace 3 semanas
Bogota, Colombia Rappi A tiempo completo¡Oye, es hora de que te unas a nosotros para mostrarle al mundo que somos la empresa que está cambiando paradigmas, donde revolucionamos las horas, los minutos y los segundos! ¿Quieres saber por qué Rappi? - ️ VEMOS OPORTUNIDADES donde otros ven problemas; - ️ VEMOS CERCANIA donde otros ven distancia; - ️ VEMOS ADRENALINA donde otros ven...
-
Regulatory Affairs Coordinator
hace 2 semanas
Bogota, Colombia Novartis A tiempo completo1.066.824. That’s the number of patients we reached in 2021. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who share your determination to tackle the world’s toughest medical...
-
Regulatory Affairs Associate Consultant
hace 1 semana
Bogota, Colombia ClinChoice A tiempo completoAre you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice is searching for a Regulatory Affairs Associate Consultant to join one of our clients. **Main Job Tasks and Responsibilities**: -...
-
Associate Regulatory Affairs Specialist
hace 1 semana
Bogota, Colombia Medtronic A tiempo completo**Careers that Change Lives** We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable...
-
Tbd Regulatory Affairs Associate 3
hace 3 semanas
Bogota, Colombia Icon plc A tiempo completoRegulatory Affairs Associate 3 JR093891 Site: Colombia (Bogotá) At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and...
-
Director Medical Affairs
hace 3 semanas
Bogota, Colombia IPSEN A tiempo completo**Title**: Director Medical Affairs **Company**: Ipsen Pharma (SAS) **Define the strategy for Medical Affairs locally and execute it**: - Create and implement strategic and operational plans in the country in line with the mission, strategy, and values of the Ipsen Group, thus achieving Global Medical Affairs and Local targets. - Secure the successful...