re 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 for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Regulatory Affairs Jr. Specialist Consultant / Especialista Jr. de Asuntos Regulatorios Location / Ubicación: Ciudad de México, México Position Summary / Resumen del puesto: Support the preparation, review and follow-up of regulatory submissions for medical devices, ensuring compliance with applicable regulations before health authorities such as COFEPRIS, enabling timely approvals and maintenance of product registrations. Apoyar en la preparación, revisión y seguimiento de trámites regulatorios para dispositivos médicos, asegurando el cumplimiento de la normativa aplicable ante la autoridad sanitaria COFEPRIS, facilitando la obtención y mantenimiento de los registros sanitarios. Key responsabilities / Responsabilidades principales: Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes). Follow up on submissions with regulatory authority (COFEPRIS). Support interpretation of local and international regulations. Support coordination of requests and activities with cross-functional teams. Maintain updated regulatory files and databases. Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones). Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS). Apoyar en la interpretaci
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Role overview
Job description
Are 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 for 12 months Contract with possibility of extension to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Responsibilities · Accountable for aligned markets for required regulatory in-scope ancillaries and samples · Understand aligned markets regulatory ancillary requirements · Manage aligned markets ancillary and sample
…What they are looking for
Skills & requirements
Qualification
Acts decisively and seizes accountability Bachelor’s degree Level (desirable or equivalent work experience; Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel; The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology
Department · Regulatory Affairs
Hiring company
ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 30 years of proven high-quality delivery and results across all our services with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. We are on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Join our passionate team and make a meaningful impact on global healthcare!
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