Regulatory Affairs Jr. Specialist Consultant

Job description

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 interpretación de normativas locales e internacionales. - Apoyar la coordinación de solicitudes y actividades con áreas internas. - Mantener actualizados archivos regulatorios y bases de datos. **Qualifications / Requisitos:** Bachelor’s degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related field. Licenciatura en Química, QFB, QFI, QBP, Farmacia, Ingeniería Biomédica, Biotecnología o afín. **Experience / Experiencia:** Minimum 1 year of experience in regulatory affairs, quality or medical device industry. **Technical skills / Conocimientos técnicos:** - Mexican medical device regulations (COFEPRIS). - Medical device classification. - NOMs and standards aplicable. - Intermediate-advanced English (technical reading required). - Intermediate Excel skills (data tracking, pivot tables, basic formulas, reporting). **Core competencies / competencias clave:** - Attention to detail. - Organizational and documentation skills. - Effective communication. - Team collaboration - Learning Agility.