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 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%



  • 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

    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 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...