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 requisitos
bachelor'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 13485 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