Ciudad de México, Mexico · On-site
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who …
Skills: Regulatory Affairs, Medical Device Regulation, Sanitary Registrations, Technical Dossier Preparation, Change Control Management
Ciudad de México, Mexico · On-site
$18k–$20k/mo
Descripción de la empresa En Doctoralia, nuestra misión es humanizar la experiencia de la salud a través de la tecnología. Como la plataforma líder en el mercado mexicano y referente global en soluciones SaaS para el sec…
Skills: Consultative Selling, Outbound Prospecting, B2B Sales, Cold Calling, Negotiation
Ciudad de México, Mexico · Remote OK
Mexico. Remote. ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collab…
Skills: Executive Support, Administrative Support, Clinical Operations, Project Management, Meeting Coordination
Ciudad de México, Mexico · Remote OK
Home Based - CDMX ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, coll…
Skills: Pharmacovigilance, Drug Safety, Adverse Event Processing, Regulatory Reporting, Attention To Detail
Ciudad de México, Mexico · Remote OK
Home -Based - CDMX ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, col…
Skills: Pharmacovigilance, Drug Safety, Adverse Event Processing, Regulatory Reporting, Data Collection
Ciudad de México, Mexico · On-site
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who …
Skills: Internal Communication, Content Design, Copywriting, Canva, Adobe Express
Ciudad de México, Mexico · Remote OK
CDMX ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, ag…
Skills: eTMF Management, Clinical Trial Documentation, Quality Oversight, Compliance Monitoring, SOP Deviations Management
Ciudad de México, Mexico · Hybrid
Kenvue is currently recruiting for a: ANALISTA SR DE CALIDAD - Fixed Term What we do At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the ho…
Skills: Quality Compliance, New Product Introduction, Risk-Based Analysis, GxP, External Auditing
Ciudad de México, Mexico · On-site
States considered: Role Description Gerente Comercial del Negocio de Cerdos en México Responsable de definir y ejecutar la estrategia comercial para el portafolio de porcinos en México, asegurando crecimiento rentable, e…
Skills: Commercial Strategy, P&L Management, Sales Leadership, Key Account Management, Market Analysis
Ciudad de México, Mexico · On-site
States considered: Role Description Gerente Comercial del Negocio de Cerdos en México Responsable de definir y ejecutar la estrategia comercial para el portafolio de porcinos en México, asegurando crecimiento rentable, e…
Skills: Commercial Strategy, Sales Leadership, P&L Management, Key Account Management, CRM Adoption
Ciudad de México, Mexico · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as an Assistant Clinical Research Associate – Make an Impact at the Forefront of Innovation We have successfully supported the top …
Skills: Clinical Research, Site Management, ICH GCP, Remote Monitoring, Medical Terminology
Ciudad de México, Mexico · Hybrid
About IQVIA IQVIA is a global leader in advanced analytics, technology solutions, and life sciences consulting. We help healthcare stakeholders drive innovation and improve patient outcomes worldwide. By combining data, …
Skills: Market Access Strategy, Quantitative Analysis, Qualitative Analysis, Data Analysis, Excel Modeling
Ciudad de México, Mexico · Hybrid
Use Your Power for Purpose The Market Supply Chain Planner is responsible for planning and executing demand and supply strategies in the Mexico market, leveraging digital tools to identify opportunities and maintain comm…
Skills: Demand Planning, Supply Chain Management, S&OP, Project Management, Data Analysis
Ciudad de México, Mexico · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Completes a wide variety of technical, logistical, facilitative and central processes that are critical to study success; Provides project …
Skills: Project Administration, Data Entry, Project Coordination, Report Preparation, Quality Review
Ciudad de México, Mexico · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Completes a wide variety of technical, logistical, facilitative and central processes that are critical to study success; Provides project …
Skills: Project Administrative Support, Data Entry, Project Coordination, Report Preparation, Quality Review
Ciudad de México, Mexico · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Completes a wide variety of technical, logistical, facilitative and central processes that are critical to study success; Provides project …
Skills: Project Administrative Support, Data Entry, Project Coordination, Report Preparation, Quality Review
Ciudad de México, Mexico · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Completes a wide variety of technical, logistical, facilitative and central processes that are critical to study success; Provides project …
Skills: Project Administrative Support, Data Entry, Project Planning, Coordination, Documentation Management
Ciudad de México, Mexico · On-site
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Completes a wide variety of technical, logistical, facilitative and central processes that are critical to study success; Provides project …
Skills: Project Administrative Support, Data Entry, Project Coordination, Report Preparation, Quality Review
Ciudad de México, Mexico · Remote OK
Senior Production Artist - Homebased - Mexico ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven o…
Skills: Adobe InDesign, Adobe Photoshop, Adobe Illustrator, Adobe Acrobat, Microsoft PowerPoint
Ciudad de México, Mexico · Remote OK
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior Project Support Coordinator Completes a wide variety of technical, logistical, facilitative and central processes that are critical …
Skills: Project Administration, Data Entry, Quality Review, Audit Readiness, Report Preparation
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Manage sanitary registrations, renewals, and modifications for medical devices and software as a medical device (SaMD) in compliance with Mexican and international laws. Oversee global change notifications, advertising permits, labeling updates, and the reporting of regulatory metrics.
Requires a degree in Pharmaceutical Chemistry, Biology, or a related health science field with fluency in English. Must have deep knowledge of Mexican health legislation (NOM-240, NOM-137, NOM-241) and international regulatory guidelines from FDA, ANVISA, and HC.
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
Un futuro más saludable. Es lo que nos impulsa a innovar. Avanzar continuamente en la ciencia y garantizar que todos tengan acceso a la atención médica que necesitan hoy y en las generaciones futuras. Crear un mundo en el que todos tengamos más tiempo con las personas que amamos. Eso es lo que nos hace ser Roche.
En Roche, creemos en la diversidad y la inclusión (DE&I) como motores de la innovación. Nos comprometemos a ofrecer un entorno de colaboración equitativo donde cada voz cuenta para transformar la salud del mañana.
Buscamos a un profesional apasionado por la regulación sanitaria en el sector de dispositivos médicos para unirse a nuestro equipo. En esta posición, serás la pieza clave para garantizar la continuidad del negocio, la introducción de nuevas tecnologías médicas (incluyendo Software as a Medical Device - SaMD) y el cumplimiento estricto del marco legal mexicano e internacional.
Si te entusiasma el análisis de datos, la estrategia regulatoria y trabajar bajo los más altos estándares globales, ¡esta oportunidad es para ti!
Responsabilidades
Como Especialista de Asuntos Regulatorios, tus funciones principales serán:
1. Gestión de Registros Sanitarios
Preparar, evaluar y someter Prórrogas, Modificaciones (técnicas o administrativas) y Nuevos Registros (vía tradicional y estrategias de Reliance con FDA, ANVISA, EU, HC y SaMD).
Evaluar cada caso (situación – producto – autorización) para determinar el trámite o gestión aplicable.
Revisar y preparar la documentación técnica para la integración del dossier regulatorio.
Asegurar el cumplimiento de la ley, la correcta identificación del producto y la vigencia del portafolio actual.
Manejar y analizar las notificaciones de cambios técnicos o administrativos globales en los productos.
Comunicar de manera oportuna el impacto regulatorio a nivel local y global.
Asegurar el sometimiento y aprobación de los procesos regulatorios en tiempo y forma para mitigar riesgos comerciales.
Preparar, someter y gestionar la autorización de Avisos o Permisos de Publicidad en alineación con el área de Estrategia.
Ejecutar el proceso de actualización de contraetiquetado, asegurando que la información técnica sea verídica y cumpla al 100% con la NOM-137.
Analizar y enviar reportes mensuales del área, asegurando el correcto envío de la estadística AMID de forma oportuna.
Monitorear el cumplimiento de KPIs y métricas para detectar e implementar acciones de mejora continua.
Mantener actualizada y vigente la documentación legal requerida para el soporte de la operación.
Profesional titulado en Químico Farmacobiólogo (QFB), QBP, QFI, IF o carrera afín a las ciencias de la salud.
Legislación Sanitaria Mexicana: Ley General de Salud, Reglamento de Insumos para la Salud y Ley Federal del Procedimiento Administrativo.
Normatividad de Dispositivos Médicos: Normas Oficiales Mexicanas vigentes, con énfasis estricto en NOM-240-SSA1 (Tecnovigilancia), NOM-137-SSA1 (Etiquetado) y NOM-241-SSA1 (Buenas Prácticas de Fabricación).
Regulación Internacional: Directrices y Regulación Sanitaria aplicable (IMDRF, FDA, ANVISA, HC).
Herramientas Digitales: Manejo intermedio de Excel (análisis de datos), Google Suite, Veeva Vault y familiaridad con plataformas regulatorias nacionales (ej. DIGIPRiS).
Idiomas: Inglés fluido conversacional
Enfoque analítico y capacidad para trabajar bajo metodologías de mejora continua.
Excelentes habilidades de comunicación y colaboración con equipos locales e internacionales.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI). For more information, please visit https://careers.roche.com Read our community guidelines here: https://www.roche.com/some-guidelines.htm #Roche #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Offices: Grenzacherstrasse, Switzerland 🇨🇭 , 4070, CH · 4414 Lake Boone Trail, Raleigh, NC 27607, US · 7070 Mississauga Rd, Mississauga, ON L5N 5M8, CA · Calle Dionisio Derteano 144, San Isidro, Lima 15047, PE · 333 Buckhead Ave NE, Atlanta, GA 30305, US
There are currently 195 open healthcare positions in Ciudad de México, Mexico listed on Clera. New openings are added daily as companies post roles.
Companies currently hiring include Thermo Fisher Scientific, ICON plc, Becton, Dickinson and Company, IQVIA, Boehringer Ingelheim, among others. Browse the listings above to see every active employer.
Yes — 97 of the 195 open healthcare positions offer remote or hybrid work (29 remote, 68 hybrid).
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.
