Regulatory Affairs Jr. Specialist Consultant

<p></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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….</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">ClinChoice is searching for a <strong>Regulatory Affairs Associate Consultant</strong>&nbsp;<strong>for 12 months Contract with possibility of extension </strong>to join one of our clients.</span></p> <p><span style="font-family: tahoma, arial, helvetica, sans-serif; font-size: 12pt;">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. &nbsp;</span></p> <p></p> <p><strong>Regulatory Affairs Jr. </strong><strong>Specialist Consultant / Especialista Jr. de Asuntos Regulatorios</strong></p> <p><strong>Location / Ubicación:</strong> Ciudad de México, México</p> <p><strong>Position Summary / Resumen del puesto:</strong></p> <p>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.</p> <p>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.</p> <p><strong>Key responsabilities / Responsabilidades principales:</strong></p> <ul> <li>Prepare and compile regulatory documentation for COFEPRIS submissions (registrations, renewals, changes).</li> <li>Follow up on submissions with regulatory authority (COFEPRIS).</li> <li>Support interpretation of local and international regulations.</li> <li>Support coordination of requests and activities with cross-functional teams.</li> <li>Maintain updated regulatory files and databases.</li> </ul> <p>&nbsp;</p> <ul> <li>Preparar y compilar documentación regulatoria para sometimientos ante COFEPRIS (registros, renovaciones, modificaciones).</li> <li>Dar seguimiento a los trámites ante autoridad regulatoria (COFEPRIS).</li> <li>Apoyar en la interpretación de normativas locales e internacionales.</li> <li>Apoyar la coordinación de solicitudes y actividades con áreas internas.</li> <li>Mantener actualizados archivos regulatorios y bases de datos.</li> </ul> <p><strong>Qualifications / Requisitos:</strong></p> <p>Bachelor’s degree in Chemistry, Pharmaceutical Chemistry, Pharmacy, Biomedical Engineering, Biotechnology, or related field.</p> <p>Licenciatura en Química, QFB, QFI, QBP, Farmacia, Ingeniería Biomédica, Biotecnología o afín.</p> <p><strong>Experience / Experiencia:</strong></p> <p>Minimum 1 year of experience in regulatory affairs, quality or medical device industry.</p> <p><strong>Technical skills / Conocimientos técnicos:</strong></p> <ul> <li>Mexican medical device regulations (COFEPRIS).</li> <li>Medical device classification.</li> <li>NOMs and standards aplicable.</li> <li>Intermediate-advanced English (technical reading required).</li> <li>Intermediate Excel skills (data tracking, pivot tables, basic formulas, reporting).</li> </ul> <p><strong>Core competencies / competencias clave:</strong></p> <ul> <li>Attention to detail.</li> <li>Organizational and documentation skills.</li> <li>Effective communication.</li> <li>Team collaboration</li> <li>Learning Agility.</li> </ul> <p>&nbsp;</p>