Responsable Sanitario

Acerca de Mozarc Medical En Mozarc Medical, nuestra visión es reinventar el futuro de la tecnología integral para la salud renal. Fundada en 2023 a partir de inversiones equitativas de DaVita, un proveedor líder de servicios de atención renal, y Medtronic, una de las mayores empresas de dispositivos médicos del mundo, Mozarc Medical ofrece una experiencia destartup emocionante y única, respaldada por el apoyo de dos líderes consolidados de la industria y del mercado. Impulsados por nuestra misión y nuestros valores, ponemos a los pacientes en el centro de todo lo que hacemos. Nuestros colaboradores desempeñan un papel clave en el desarrollo de soluciones tecnológicas que mejoran la vida de los pacientes y generan avances significativos en el tratamiento de la enfermedad renal. Encuentra tu propósito y tu pasión en Mozarc Medical. The Principal Responsable Sanitario (RS) is the legally designated health professional responsible for ensuring sanitary compliance of the warehouse/distribution establishment in accordance with COFEPRIS regulations, the Ley General de Salud, and applicable NOMs. The RS serves as the official liaison with COFEPRIS for the establishment and ensures that regulated storage and distribution activities meet all regulatory requirements. This role operates within a third-party logistics (3PL) establishment and works in coordination with Mozarc as the Mexico Registration Holder (MRH) to ensure regulatory alignment. 3PL: Kuehn + Nagel, located at Carretera Tepotzotlán la Aurora KM. 1, S/N Col. Axotlán C.P. 54719. Responsable Sanitario Responsibilities: - Ensure that all storage and distribution activities comply with COFEPRIS regulations, the Ley General de Salud, and applicable NOMs, including NOM-241-SSA1-2021 for medical devices. - Ensure the establishment maintains a valid Aviso de Funcionamiento and that all activities remain within its authorized scope. - Act as the legally registered Responsable Sanitario before COFEPRIS and maintain active registration as the Responsible Sanitario in the DIGIPRiS platform. - Oversee sanitary conditions, hygiene practices, and regulatory compliance within the warehouse/distribution environment. - Ensure proper storage, handling, and traceability of regulated products. - Maintain and control regulatory documentation including permits, notices, logs, and traceability records. - Serve as the primary contact during COFEPRIS inspections and ensure continuous inspection readiness. - Support local complaint handling, documentation, and escalation to Mozarc’s global vigilance function in accordance with NOM-240. Support may be provided for local regulatory interactions as required. - Provide training and guidance to personnel on sanitary regulations and compliance requirements. - Implement and monitor corrective and preventive actions related to regulatory findings. - Ensure regulatory impact assessment of changes affecting storage, distribution, or traceability and coordinate with Mozarc through change control processes. Required Skills - Bachelor’s degree required. - Professional degree (Título) in a health-related discipline (e.g., Químico, QFB, Farmacéutico, Médico, etc.). - Valid professional license (Cédula Profesional). - Eligibility to be registered as Responsable Sanitario with COFEPRIS. - Minimum 7 years of experience in regulated industries - Demonstrated knowledge of COFEPRIS regulations, NOMs, and Mexican sanitary legislation. - Experience supporting regulatory inspections or compliance programs. Key Competencies - Strong understanding of regulatory compliance requirements - High ethical standards and accountability - Excellent documentation and organizational skills - Effective communication with authorities and stakeholders - Ability to work independently and make compliance-based decisions Todos los solicitantes calificados recibirán conideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, origen nacional, discapacidad o condición de veterano protegido. ¿Es éste el puesto que estaba esperando? Presente su candidatura aquí.