Trabajos
>
Bogotá

    Regulatory Affairs Specialist - Bogotá, Colombia - Zimmer Biomet

    Zimmer Biomet
    Zimmer Biomet Bogotá, Colombia

    hace 6 días

    Default job background
    De jornada completa
    Descripción
    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 to people around the world.

    To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards.

    We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.

    What You Can Expect


    Responsible for assisting the team with regulatory change assessments and filings as necessary to market and maintain Zimmer Biomet products.

    This position requires an intermediate understanding of medical devices and their use as well as a understanding of the regulatory pathways (US and EU) for change assessment through approval.

    How You'll Create Impact


    • Provide regulatory assessment of product changes (including but not limited to material, manufacturing, cleaning, sterilization, and packaging changes), utilizing both local procedure and established regulatory guidance and standards
    • Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the
    regulatory process, including the regulatory submissions process. May author and publish

    electronic submissions


    • Respond to requests from foreign government and/or distributors as needed
    • Assist with the research, analysis and communication of information pertaining to the
    appropriate regulatory pathway for approval of product changes


    • Provides regulatory direction to development project teams as a core team member; develops
    regulatory strategy for significant product changes


    • Evaluate risk of proposed regulatory strategies; may offer solutions
    • Reviews proposed labeling for compliance with applicable global regulations
    • Updates package inserts and labeling to support product changes as appropriate
    • Communicates with regulatory and governmental agencies with supervision
    • Applies FDA regulations to business practices and provides regulatory input, advice and
    guidance to design teams

    What Makes You Stand Out


    • 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 build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels and cross-functionally
    • Knowledge of FDA, EU, and other regulatory body regulations
    • Ability to identify risk in Regulatory strategies
    • Strong problem solving skills
    • Basic computer skills, including Microsoft Office Suite
    Your Background

    Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred


    • A minimum of one year of experience in orthopaedic or medical device industry preferred
    • A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
    • Regulatory Affairs Certification (US or EU) preferred
    • A combination of education and experience may be considered
    Travel Expectations

    Up to 15%

    EOE/M/F/Vet/Disability
  • Takeda Pharmaceutical

    Regulatory Affairs Specialist

    hace 3 días

    Takeda Pharmaceutical Bogota, Colombia

    **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 la ...

  • ARIAD

    Regulatory Affairs Specialist

    hace 1 semana

    ARIAD Bogota, Colombia

    **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 E ...

  • bioMérieux sa

    Regulatory Affairs Specialist

    hace 1 semana

    bioMérieux sa Bogota, Colombia

    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 ...

  • Abbott Laboratories

    Specialist Regulatory Affairs

    hace 1 semana

    Abbott Laboratories Bogota, Colombia

    **RA Specialist** · **Acerca de Abbott** · Abbott es líder mundial en cuidado de la salud, que crea ciencia innovadora para mejorar la salud de las personas. Siempre estamos mirando hacia el futuro, anticipando cambios en la ciencia y la tecnología médica. · **Trabajando en Abbot ...

  • Nu Skin

    Regulatory Affairs Specialist

    hace 1 semana

    Nu Skin Bogota, Colombia

    PRINCIPALES ACTIVIDADES: · - Proveer y analizar la regulación y exigencias propias de cada producto con fines de registro, soportando el sometimiento y preparación de respuestas a requerimientos de las autoridades sanitarias. · - Gestionar y proveer la documentación técnica y leg ...

  • Medtronic

    Regulatory Affairs Specialist

    hace 3 días

    Medtronic Bogota, Colombia

    **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 ...

  • Johnson & Johnson

    Regulatory Affairs Specialist

    hace 4 días

    Johnson & Johnson Bogota, Colombia

    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 h ...

  • AbbVie

    Regulatory Affairs Specialist

    hace 2 días

    AbbVie Bogota, Colombia

    **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 ...

  • Zimmer Biomet

    Regulatory Affairs Specialist

    hace 1 semana

    Zimmer Biomet Bogota, Colombia

    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 m ...

  • Zimmer Biomet

    Regulatory Affairs Specialist

    hace 5 días

    Zimmer Biomet Bogota, Colombia

    **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 d ...

  • ICON

    Medical Affairs Specialist

    hace 1 semana

    ICON Bogota, Colombia

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. · We offer challengi ...

  • Medtronic

    Associate Regulatory Affairs Specialist

    hace 2 días

    Medtronic Bogota, Colombia

    **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 pa ...

  • Rappi

    Compliance and Regulatory Affairs Specialist

    hace 1 semana

    Rappi Bogota, Colombia

    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 do ...

  • Vantage Specialty Chemicals

    Regulatory Affairs Specialist Latam

    hace 3 días

    Vantage Specialty Chemicals Bogota, Colombia

    Vantage is a leading supplier of naturally derived specialty ingredients and formulations that cater to the evolving needs of industrial and consumer markets. Through our chemistries, our customer focus and our global footprint, we are ENABLING TOMORROW'S SOLUTIONS TODAY. · As a ...

  • Zimmer Biomet

    Regulatory Affairs Specialist

    hace 6 días

    Zimmer Biomet Bogotá, Colombia

    At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission 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 As a Zimmer Biomet team member, you will shar ...

  • Zimmer Biomet

    Regulatory Affairs Specialist

    hace 1 semana

    Zimmer Biomet Bogotá, Colombia

    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 memb ...

  • Zimmer Biomet

    Regulatory Affairs Specialist

    hace 6 días

    Zimmer Biomet Bogotá, Colombia External

    JOB DESCRIPTION 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 Zi ...

  • Vantage Specialty Chemicals

    Regulatory Affairs Specialist LATAM

    hace 3 días

    Vantage Specialty Chemicals Bogotá, Colombia De jornada completa

    Vantage is a leading supplier of naturally derived specialty ingredients and formulations that cater to the evolving needs of industrial and consumer markets. Through our chemistries, our customer focus and our global footprint, we are ENABLING TOMORROW'S SOLUTIONS TODAY. · As a ...

  • Zimmer Biomet

    Regulatory Affairs Assoc Specialist

    hace 1 semana

    Zimmer Biomet Bogotá, Colombia External

    JOB DESCRIPTION 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 Zim ...

  • Zimmer Biomet

    Regulatory Affairs Assoc Specialist

    hace 6 días

    Zimmer Biomet Bogotá, Colombia De jornada completa

    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 m ...