Medical Equipment Regulatory Affairs Coordinator
hace 4 días
**Vacante para la empresa Worldwide Asian global leading manufacturer, developer and distributor of medical devices en Benito Juárez, Ciudad de México**:
**Worldwide Asian global leading manufacturer, developer and distributor of medical devices requieres**:
**Medical equipment regulatory affairs/Quality assurance coordinator**
Ensure that the company has all documents (Licenses, Importations permits, SOPs, certifications, or any other document) and that the activities are performed according to the Local requirements of the countries for which the companyis responsible (Mexico, Cuba, Caribe, Dominican Republic, Guatemala, Honduras, El Salvador, Nicaragua, Costa Rica, Panama, Colombia, Peru, Ecuador, Bolivia & Venezuela), allowing the commercialization of our medical devices
**Main Accountabilities**
- Get Licenses (Sanitary Registrations for medical devices group products)
- Assembling dossiers and submitting them to the local Governmental Institution responsible of it.
- Local compliance for commercialization of the product in the respective countries.
- Maintenance of current licenses.
- Gathering documentation, according to local requirements, for amendments or renewals of Licenses
- Keep Licenses updated and valid for commercialization of the products according to the current portfolio.
- Support to distributors for their licenses obtention our maintenance
- Gathering documentation, according to local requirements, for amendments or renewals of Licenses
- Keep Licenses updated and valid for commercialization of the products according to the current portfolio.
- Quality Assurance.
- Local compliance with regulation
**We offer**
- Very competitive compensation
- Benefits superior to those established by law
- International growth and continuous training
**Nível de educación deseada**:
Superior - titulado
**Nível de experiência deseada**:
Nível Experto
**Función departamental**:
Medicina / Salud
**Industria**:
Dispositivos Médicos
**Habilidades**:
- medical equipment
- regulatory affairs
- quality assurance
-
Regulatory Affairs Specialist
hace 3 semanas
Tlahuac, México Bayer A tiempo completo**Regulatory Affairs Specialist****Position purpose**Act as LRA (Local RA) for all the daily activities that will ensure registrations of Radiology Medical Devices are properly done in LATAM region by submitting local dossiers, keeping country requirement table and SharePoint site folder structure updated, and ensuring the proper trackers are up to date.Keep...
-
Manager Regulatory Affairs Affiliate
hace 2 semanas
Tlahuac, México Lilly A tiempo completoAt 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 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 communities...
-
Regulatory Affairs Specialist, Export Countries
hace 2 semanas
Tlahuac, México Solventum A tiempo completo**Job Description**: Regulatory Affairs Specialist, Export Countries (Solventum) Mexico City 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the...
-
Regulatory Affairs Specialist
hace 1 semana
Tlahuac, México Edwards Lifesciences A tiempo completoMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...
-
Regulatory Affairs and Policy
hace 4 semanas
Tlahuac, México HSBC A tiempo completo-Job description**Role purpose**:Regulatory Affairs deals with regulators and / or regulatory developments affecting the Bank, and in particular as they relate to Compliance risks, which include and are not limited to:- Regulatory Engagement: Delivering proactive and more consistent management and oversight of regulator relationships...
-
Regulatory Affairs Specialist
hace 2 semanas
Tlahuac, México Edwards Lifesciences A tiempo completoMake a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...
-
Regulatory Affairs Associate Consultant
hace 2 semanas
Tlahuac, México 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**:-...
-
Vaccines Medical Lead
hace 3 semanas
Tlahuac, México Pfizer A tiempo completoMEDICAL:- Ensures that medical team provides support and the necessary medical and scientific information of Pfizer Biopharmaceutical Group products to internal and external customers assuring compliance with Corporate and Local Procedures and applicable regulations providing full support to our local medical objectives.- Identifies, support and coordinate...
-
Regulatory Affairs Jr Specialist
hace 2 semanas
Tlahuac, México Johnson & Johnson A tiempo completoDescription Kenvue is currently recruiting for: **Regulatory Affairs Jr Specialist** This position reports to Latam CMC Regulatory Affairs Manager and is based at Mexico City. **Who we are** At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands -...
-
Regulatory Affairs Manager Jr
hace 4 días
Tlahuac, México Zoetis A tiempo completo**Role Description** The Regulatory Affairs Manager Jr. (RAMJr.) will be responsible for executing the strategies previously defined by the RASrM, will also support the promotion of compliance, advising other Departments about local regulations (COFEPRIS, SADER and PROFECO) and global procedures. Together with the RASrM, will identify possible impacts of...