MSc in Regulatory Affairs and Quality Assurance in Medical Technologies
This master's program prepares students to navigate complex regulatory landscapes in the medical devices and life sciences industries. The curriculum covers regulatory requirements for pharmaceuticals, biotechnology, medical devices, food, and cosmetics across their entire lifecycle.
Credits
30 Credit Hours
Duration
Part-time or Full-time
Format
100% Online
Specialization Tracks
Medical Devices
Focus on FDA, CE marking, and global medical device regulations
Pharmaceuticals
Emphasis on drug approval processes and pharmaceutical compliance
Curriculum Highlights
Our comprehensive curriculum covers all essential aspects of regulatory affairs and quality assurance.
Learning Outcomes
Upon completion of this program, graduates will be able to:
Recognize legal, regulatory requirements, and quality assurance procedures for all device development stages
Apply guidelines and testing protocols for clinical trials in medical device contexts
Navigate complex regulatory environments and ensure compliance with applicable industry standards
Implement quality management systems according to ISO standards
Conduct risk management assessments and develop mitigation strategies
Lead regulatory submissions and interact effectively with regulatory authorities
Career Opportunities
Graduates pursue diverse careers in regulatory affairs and quality management.
Regulatory Affairs Specialist
Manage product registrations and regulatory submissions
Regulatory Affairs Manager
Lead regulatory strategy and team management
Compliance Officer
Ensure organizational adherence to regulations
Quality Assurance Manager
Oversee quality systems and continuous improvement
Clinical Research Associate
Coordinate clinical trials and regulatory compliance
Quality Control Analyst
Perform testing and validation activities
Ready to Start Your Journey?
Become an expert in regulatory affairs and quality assurance in the medical technology industry.