Program Description

The Master of Science in Regulatory Affairs and Quality Assurance in Medical Technologies equips students with the knowledge and skills necessary to navigate the complex regulatory landscape and manage compliance with applicable laws, regulations, and standards in the devices and life sciences industry. The program focuses on the study of the regulatory and quality requirements related to the development, approval, marketing and manufacturing of products in various industries, such as pharmaceuticals, biotechnology, medical devices, food, and cosmetics. This program is designed to provide students with the knowledge and skills necessary to understand and comply with complex regulatory environments to ensure that products meet regulatory and quality requirements and relevant laws and regulations. Students can advance their knowledge of international regulatory affairs laws and procedures while also gaining the leadership skills necessary to succeed in the fields of regulatory science and quality assurance. The 30-credit Medical Device Regulatory Affairs stream specialization of the Master of Science in Medical Devices, Regulatory Affairs, and Health Information Technologies is available.

With concentrations on Medical Devices and Pharma, the Master of Science in Regulatory Affairs and Quality Assurance in Medical Technologies at Aleph prepares interdisciplinary professionals to address current and future challenges and opportunities in the market.

El plan de estudios del Máster en Asuntos Regulatorios y Garantía de Calidad en Tecnologías Médicas incluye cursos que cubren temas como ética y liderazgo, estrategia regulatoria, ensayos clínicos, garantía de calidad, gestión de riesgos, desarrollo de productos, regulaciones globales y análisis estadístico. Los estudiantes también aprenderán sobre sistemas de gestión de calidad, procesos de validación y técnicas de auditoría.

Reconocer los requisitos legales, reglamentarios y los procedimientos de garantía de calidad para todas las etapas de los dispositivos.
Demostrar capacidad para aplicar pautas y probar todas las facetas de los ensayos clínicos para dispositivos.
Navegue por el complejo panorama regulatorio y gestione el cumplimiento de las leyes, regulaciones y estándares aplicables en la industria de dispositivos y ciencias biológicas.

The Master of Science in Regulatory Affairs and Quality Assurance in Medical Technologies program prepares students to become leaders in the regulatory field, prepared to manage the regulatory processes required to market compliant medical devices and products, as well as to work with a government agency to assure consumer safety. The program provides students with the knowledge and skills needed to navigate complex regulatory environments, ensure compliance with applicable regulations, and maintain high-quality standards for products. Graduates of this program play a crucial role in ensuring that products are safe, effective, and meet regulatory and quality requirements.

Upon completion of this program, students will be able to:

Recognize the legal, regulatory requirements and quality assurance procedures for all stages of devices.
Demonstrate ability to apply guidelines and test all facets of clinical trials for devices.
Navigate the complex regulatory landscape and manage compliance with applicable laws, regulations, and standards in the devices and life sciences industry.

Career Opportunities

Graduates of the Master of Science in Regulatory Affairs and Quality Assurance in Medical Technologies program can pursue a range of career opportunities in the fields of regulatory affairs, quality assurance, and compliance, including roles such as regulatory affairs specialist, quality assurance manager, compliance officer, and clinical research associate. The graduates may work in a variety of settings, including pharmaceutical, biotechnology and medical device companies, government agencies, contract research organizations, and consulting firms.

Some career opportunities include:

Regulatory Affairs Specialist/Manager
Compliance Officer/Manager
Regulatory Consultant
Government Regulatory Agency Staff
Quality Assurance Specialist/Manager
Clinical Research Associate/Manager
Regulatory Consultant
Quality Control Analyst

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