Regulatory Affairs Supervisor

hace 4 semanas

Tecate, México Scantibodies A tiempo completo

Descripción y detalle de las actividades- Oversee and coordinate the implementation of regulatory policies and procedures: Ensure compliance with regulations and standards in all of the aforementioned areas.- Develop and maintain relationships with regulatory authorities:- Establish and maintain relationships with regulatory authorities to obtain information and advice on regulations and standards.- Train and advice staff: Train and advice staff on regulations and standards applicable to their work areas.- Investigate and resolve regulatory issues: Investigate and resolve regulatory issues that arise in the various areas mentioned above.- Develop and implement compliance plans: Develop and implement compliance plans to ensure compliance with applicable regulations and standards.- Collaborate with other departments: Collaborate with other departments, such as quality, safety, and operations, to ensure compliance with regulations and standards.Experiência y requisitosBachelor's degree in a regulatory-related discipline, such as law, biological sciences, or chemistry.Experience in regulatory affairs in at least four of the following areas.- Chemical laboratories: Experience in chemical handling regulations, laboratory safety, and quality compliance.- Medical clinics: Experience in healthcare regulations, patient safety, and quality compliance.- Nuclear: Experience in nuclear safety regulations, radioactive materials handling, and safety compliance.- Schools: Experience in school safety regulations and quality compliance.- Imports and exports of human and animal serum to and from Mexico, the US, and China: Experience in biological product import and export regulations, and quality and safety compliance.- Restaurants: Experience in food safety regulations, and quality and safety compliance.- Transportation: Experience in regulations on the transportation of materials, personnel, and radioactive materials, and quality and safety compliance.Experience in project management and team leadership.Knowledge of standards such as ISO ***** and FDA 21CFR 820 is required.Beneficios- Beneficios de acuerdo a la LFT**Número de vacantes** 1**Área** Calidad**Contrato** Permanente**Modalidad** Presencial**Turno** Diurno**Jornada** Tiempo Completo**Horario**- Tiempo completo- Lunes a viernes- Turno Vespertino**Estudios** Carrera con título profesional**Inglés**Hablado: Avanzado, Escrito: Avanzado**Disponibilidad p.viajar** Si

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