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.

The curriculum in the Master of Science in Regulatory Affairs and Quality Assurance in Medical Technologies program includes courses that cover topics such as ethics and leadership, regulatory strategy, clinical trials, quality assurance, risk management, product development, global regulations, and statistical analysis. Students will also learn about quality management systems, validation processes, and auditing techniques.

Program Objective

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:

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: