Regulatory Affairs Expert

hace 3 días


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

Overview

At 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 Role

The Regulatory Affairs Specialist will lead regulatory activities for Latin America, ensuring compliance with regional regulations. This role requires collaboration with stakeholders, effective time management, and attention to detail.

Responsibilities:

  • Plan and execute regulatory strategies for LATAM, including initial submissions, amendments, and changes.
  • Design and manage monographs for Brazilian submissions.
  • Coordinate translations for clusters under responsibility.
  • Build dossiers for all LATAM countries, ensuring accuracy and completeness.
  • Communicate effectively with Business Partners and Operating Units to ensure submission planning.
  • Answer government questions and follow up on RACs/RANs that need submission and prior approval.

Requirements

To succeed in this role, you should have:

  • Bachelor's or Master's degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or a related field.
  • 2 years of relevant experience in regulatory affairs or a similar role.
  • Advanced proficiency in Spanish and English (reading, writing, and speaking).
  • Portuguese language skills are desirable.
  • Experience in medical devices or pharmaceutical industry is preferred.

What We Offer

As a Regulatory Affairs Specialist at Medtronic, you can expect a competitive salary of $120,000 per year, flexible benefits package, and opportunities for growth and development. You'll be part of a global team that shares a passion for improving healthcare and making a difference in people's lives.



  • Bogotá, Bogotá D.E., Colombia Biom?Rieux Bv A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs and Pharmacovigilance Expert to join our team at Biom?Rieux Bv. The successful candidate will be responsible for ensuring compliance with local laws and regulations, as well as executing local Pharmacovigilance and Regulatory Affairs processes and activities.Key ResponsibilitiesCollaborate with...


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

    Regulatory Affairs Coordinator - Job SummaryGalderma Pharma S.A seeks a skilled Regulatory Affairs Coordinator to implement regulatory programs, processes, and policies to support regulatory activities related to product regulatory, drugs CMC regulatory, regulatory operations, and scientific medical writing.Key Responsibilities:Implement Regulatory Affairs...


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

    Join Our Team at GaldermaWe are seeking a highly skilled Regulatory Affairs Analyst to join our team at Galderma, a leading dermatology company. As a Regulatory Affairs Analyst, you will play a critical role in ensuring the compliance of our products with regulatory requirements and ensuring the timely delivery of all information related to the management of...

  • Regulatory Affairs Expert

    hace 3 semanas


    Bogotá, Bogotá D.E., Colombia dsm-firmenich A tiempo completo

    Job DescriptionJob Title: Regulatory Affairs Senior ManagerLocation: Colombia / BogotáJob Type: Full-timeAbout Usdsm-firmenich is a leading innovator in nutrition, health, and beauty, dedicated to creating essential solutions for life, desirable for consumers, and more sustainable for the planet.Job SummaryWe are seeking a highly skilled Regulatory Affairs...


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

    As a key member of the Galderma team, you will play a pivotal role in shaping the future of dermatology. We are seeking a highly skilled Regulatory Affairs professional to join our team and contribute to our mission to advance dermatology for every skin story.Key ResponsibilitiesImplement Regulatory Affairs programs, processes, and policies to support...


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

    Join Our Team as a Regulatory Affairs CoordinatorGalderma is a leading dermatology company with a rich legacy and a commitment to innovation. We are seeking a highly skilled Regulatory Affairs Coordinator to join our team.About the RoleThis is an exciting opportunity to work in a dynamic and fast-paced environment, supporting the development and...


  • Bogotá, Bogotá D.E., Colombia Boston Scientific A tiempo completo

    About the RoleThe Regulatory Affairs Manager will lead a team of experts with complex projects, working collaboratively with the business to seek efficiencies in current operations, challenge the team to find alternative regulatory strategies, and work hand-in-hand with the business as a whole.Key ResponsibilitiesParticipate and advocate with external...


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

    Regulatory Affairs Specialist Job DescriptionKey Responsibilities:Develop and execute regulatory strategies to ensure compliance with global and affiliate regulations.Represent the area on global regulatory product teams and lead area regulatory product teams to identify and compile information for regulatory submissions.Interface with partner functions to...


  • 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 Werfen A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans for products marketed by Werfen.Key ResponsibilitiesEnsure compliance with regulatory and quality record management processes.Lead and manage non-conformities, follow-up plans for CAPAs.Document tracking and...


  • Bogotá, Bogotá D.E., Colombia Boston Scientific A tiempo completo

    Job OverviewWe are seeking a highly motivated and detail-oriented Regulatory Intern to join our team at Boston Scientific. As a Regulatory Intern, you will have the opportunity to develop your skills in regulatory affairs and contribute to the success of our company.Key ResponsibilitiesAssist in process optimization projects for the regulatory affairs area,...


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

    As a key member of the Werfenlife SA. team, you will play a vital role in ensuring the quality and regulatory compliance of our medical devices. Your expertise in Quality Assurance and Regulatory Affairs will be instrumental in supporting the implementation and execution of regulatory and quality plans.Key Responsibilities:Support RAQA management with a...


  • 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, 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...

  • Regulatory Affairs Lead

    hace 1 semana


    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, Bogotá D.E., Colombia 535 ICR Colombia - COL A tiempo completo

    Project Manager - Language ServicesWe are seeking a highly skilled Regulatory Affairs Specialist to join our Language Services team at ICON, a world-leading healthcare intelligence and clinical research organization.Salary: $80,000 - $120,000 per year, depending on experience.Job Description:As a Regulatory Affairs Specialist, you will play a crucial role in...


  • Bogotá, Bogotá D.E., Colombia Clínica Colombia ES A tiempo completo

    About the PositionClínica Colombia ES is seeking a highly skilled Regulatory Affairs Specialist to join our team in Bogota, Colombia. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the successful planning and execution of clinical trials and the regulatory approval of new drugs.Key Responsibilities:Regulatory Document...


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

    Job Summary Regulatory Affairs Specialist. Focused on Product Compliance and business support. Accountable to execute regulatory strategy in the Andean Region. Main focal point to the Functional Ingredients Business. Good relationship skills and food regulatory knowledge (Andean) are required. Participation in Trade Associations is expected. English is a...


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

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfenlife SA.Main ResponsibilitiesSupport the implementation and execution of regulatory and quality plans.Perform regulatory activities for products marketed by Werfenlife SA.Key AccountabilitiesSupport RAQA management with a business focus.Ensure compliance with...