The regulatory affairs professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance to state, federal and international medical device regulations for safety and efficacy.
Regulatory affairs is one of the most in-demand professions in the medical device industry. Regulatory affairs opportunities include the Food and Drug Administration (FDA) or international pre-market submissions, post-market surveillance and regulatory compliance activities. Graduates of the program have gone on to work for 3M, Medtronic, Boston Scientific and the FDA.
In successful medical device companies, regulatory professionals are involved in all stages of the commercialization process, from initial business planning to design, development, verification, pre-clinical, clinical, manufacturing, packaging, labeling, marketing and post-market surveillance.
The regulatory profession requires versatile individuals with excellent communications skills and a broad knowledge of:
Increasingly, the success or failure of medical device businesses depends on regulatory affairs, clinical and reimbursement strategies and implementation. As a result, regulatory professionals are taking leadership roles within medical device organizations, and the demand for well-trained and skilled regulatory professionals is growing significantly.
Each year, the College of Science and Engineering holds a networking and job fair for students in its Medtech master's degree programs on an annual basis with 15 - 20 MedTech industry companies, including the seven largest medical device companies in Minnesota, participating.
This represents more than two-thirds of the medical device employment in Minnesota.