Regulatory Affairs Specialist

hace 1 mes

Mexico City Zimmer Biomet A tiempo completo
JOB DESCRIPTION

En Zimmer Biomet, creemos en ampliar los límites de la innovación e impulsar nuestra misión. Como líder mundial en tecnología médica desde hace casi 100 años, cada ocho segundos la movilidad de un paciente mejora gracias a un producto o una tecnología de Zimmer Biomet.
Como miembro del equipo de Zimmer Biomet, compartirá nuestro compromiso de proporcionar movilidad y una vida renovada a personas de todo el mundo. Para apoyar a nuestro equipo de profesionales, nos centramos en oportunidades de desarrollo, grupos de recursos de empleados (ERG) sólidos, un entorno de trabajo flexible, recompensas totales competitivas específicas de la ubicación, incentivos de bienestar y una cultura de reconocimiento y premios en función del desempeño. Nos comprometemos a crear un entorno en el que todos los miembros del equipo se sientan incluidos, respetados, reconocidos y dotados de las herramientas adecuadas.
 


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 Mexico.

Cómo creará impacto

• Preparation, assembly, storage, tracking and retrieval of information pertinent to the regulatory processes, including the regulatory submissions process. May author and publish 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 Mexico, working closely with Business Unit Regulatory Teams to request information.

• 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

• Post-market Surveillance: Supports processing of product complaints, field actions and product recalls

• Reviews and evaluates promotional and advertising material for compliance with applicable regulations and procedures

• Reviews proposed product changes for impact on regulatory status of the product

• Communicates with regulatory and governmental agencies with supervision

• Applies regulations to business practices and provides regulatory input, advice and guidance to cross-functional teams

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Qué hace que destaque

Strong writing, communication, and interpersonal skills Strong attention to detail; ability to multi-task and balance competing priorities Knowledge of overall business environment, the orthopedic industry, and the marketplace Ability to learn and stay abreast of regulations pertinent to medical devices, biologics 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 Latin America regulatory body regulations and other regions such as US and EU Ability to identify risk in Regulatory strategies Strong problem solving skills Effective negotiating skills Basic computer skills, including Microsoft Office Suite

Su experiencia

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 orthopaedic 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

Expectativas de viaje

Up to 10%


EOE/M/F/Vet/Discapacidad

  • Sr Regulatory Affairs Specialist

    hace 3 meses

    Mexico City Thermo Fisher Scientific A tiempo completo

    In this role as a , you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy technical/project leadership on a regional/global...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Mexico City Solventum A tiempo completo

    Gracias por tu interés en trabajar para nuestra empresa. Contar con el talento adecuado es crucial para lograr nuestros objetivos. El 01 de abril de 2024, 3M Healthcare experimentó una separación corporativa que condujo a la creación de una nueva empresa denominada Solventum. Aún, estamos en el proceso de actualizar nuestra página de carreras y los...

  • Regulatory Affairs Specialist

    hace 1 mes

    Mexico City Zimmer Biomet A tiempo completo

    En Zimmer Biomet, creemos en ampliar los límites de la innovación e impulsar nuestra misión. Como líder mundial en tecnología médica desde hace casi 100 años, cada ocho segundos la movilidad de un paciente mejora gracias a un producto o una tecnología de Zimmer Biomet. Como miembro del equipo de Zimmer Biomet, compartirá nuestro compromiso de...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Mexico City Abbott A tiempo completo

    The Opportunity We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our rapid diagnostics solutions are helping address some of the...

  • Regulatory Affairs Specialist

    hace 6 días

    Mexico City Abbott A tiempo completo

    The Opportunity We’re empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people. Our rapid diagnostics solutions are helping address some of the...

  • Regulatory Affairs Coordinator

    hace 2 meses

    Mexico City Novo Nordisk AS A tiempo completo

    Position for Novo Nordisk GBS Mexico Are you passionate about regulatory affairs? Do you have experience in managing submissions and approvals? We are looking for a Regulatory Affairs Coordinator to join our team in GBS Mexico City. Read more and apply today for a life-changing career. Join Novo Nordisk for a life-changing career establishing and...

  • Regulatory Affairs Specialist, Consumer Business Group.

    hace 4 semanas

    Mexico City 3M A tiempo completo

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: Collaborate with innovative 3Mers around the world As...

  • Regulatory Affairs

    hace 2 semanas

    Mexico City Connectingology A tiempo completo

    Buscamos un Regulatory Affairs con experiencia en dispositivos médicos y conocimiento en regulaciones ISO y normativas específicas de la región LATAM. Este rol es clave en la gestión y mejora del Sistema de Gestión de Calidad (QMS) para la región, cumpliendo con requisitos regulatorios de ANVISA y otras normativas de buenas...

  • Regulatory Affairs Specialist

    hace 6 meses

    City, México ICON plc A tiempo completo

    Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs but may be in other related areas. - As member of the Regulatory Submissions team, you will contribute to at least one of the following activities: - Preparation,...

  • Senior Public Affairs Manager

    hace 4 meses

    Mexico City Novo Nordisk AS A tiempo completo

    Are you experienced in public affairs and public relations? Do you have a passion for working in the pharmaceutical industry? We are looking for a Senior Public Affairs Manager to join our External Affairs department at Novo Nordisk. If you are ready to make a difference and enhance our positive relations with external audiences, then read on and apply...

  • Government Affairs and Sustainability Manager for Mexico

    hace 4 semanas

    Mexico City 3M A tiempo completo

    3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: Government Affairs and Sustainability Manager ...

  • Regulatory & Start Up Specialist, cFSP

    hace 5 meses

    Mexico City IQVIA A tiempo completo

    We are looking for a Regulatory & Start Up Specialist to join our cFSP team in a Home Based role! Location : Argentina & México What You´ll Do Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project...

  • Wireless Regulatory Engineer.

    hace 6 meses

    Mexico City Cisco A tiempo completo

    What You’ll Do As a radio spectrum engineering technical leader, you will be a key member of the team responsible for promoting a healthy ecosystem for Cisco’s wireless products by supporting global harmonization of spectrum policy with a particular focus on the South American market.  You will be responsible for developing and presenting...

  • Staff Customer Regulatory Compliance Support Specialist

    hace 4 meses

    Mexico City Lenovo A tiempo completo

    Description and Requirements job Overview:  Lenovo’s Corporate Regulatory Compliance, Standards and ISO team, located in Lenovo’s US headquarters location, is presently hiring a Customer Regulatory Compliance Support Specialist to be a part of the Corporate Compliance team. This position will be located in Mexico City. This job will be...

  • FSP - Regulatory and Start Up Specialist MEX

    hace 6 meses

    Mexico City IQVIA A tiempo completo

    We are looking for a Regulatory & Start Up Specialist to join our FSP team in a Home Based role! Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary...

  • Start-up & Regulatory Specialist

    hace 6 meses

    Mexico City MEX Labcorp Clinical Development, S. de R.L. de C.V. A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Regulatory & Start Up Specialist 2, cFSP

    hace 5 meses

    Mexico City IQVIA A tiempo completo

    Regulatory & Start Up Specialist, c FSP. Location: Mexico - Full home based Job Overview This position will be responsible for participating in end-to-end site management from feasibility to site closure, serving as a point of contact for investigative sites and the study team members. This includes supporting site qualification , site level...

  • Medical Excellence Operations Manager

    hace 2 meses

    Mexico City Novo Nordisk AS A tiempo completo

    Are you passionate about ensuring strategic alignment and operational excellence? Do you have experience in project management within the pharmaceutical industry? If so, you might be the perfect fit for our Medical Excellence Operations Manager position. Read more and apply today for a life-changing career. Position Description As a Medical Excellence...

  • Sr Manager, Medical Affairs LATAM

    hace 3 meses

    Mexico City Reckitt A tiempo completo

    Sr Manager, Medical Affairs LATAM City: Ciudad de Mexico We are ReckittHome to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to...

  • Sustainability Specialist

    hace 5 meses

    Mexico City iPS - Powerful People A tiempo completo

    Short description We are looking for a Sustainability Specialist to work for an International Oil & Gas company. This is an excellent opportunity to continue to build a great career. Function description As a Sustainability Specialist your main responsabilitie will be: Perform the sustainability assessments for every stage for DG’s...