All medical technologies, including medical equipment, implanted devices, and biotechnological advancements, are also subject to federal and international regulation to ensure their safety, efficacy, and performance. The work of regulatory professionals is continuously shifting and expanding due to evolution in law, regulatory environments, technology, and global economics. Keep your regulatory knowledge base current by scanning multiple sources of regulatory affairs material daily to stay up-to-date on global changes in food and drug regulation. Despite these stringent regulations, the rapid development of new medical technology and the increasing accessibility of food from around the globe introduce new risks to the market daily. The work is very detail-focused, as it involves writing and reviewing documents that are thousands of pages long. It requires an understanding of science and business, as well as government language and procedures. The pressure can be intense–but it’s important work, and for scientists with the right mindset it can be an excellent career. Thus, it is now a global imperative to develop and improve state, federal, and international regulations to maintain the innovation and release of food and biomedical products to global markets.
As the regulatory affairs discipline plays an integral role in global health, food safety, and medical innovation, it’s no surprise that the job market is growing. In 2020, the U.S. regulatory market experienced a 51 percent increase in job listings, and the U.S. Bureau of Labor Statistics estimates the field will continue to grow at an average rate of eight percent until 2029. As new and developing industries become increasingly regulated, the demand for additional and specialized regulatory expertise will increase. You’ll need an aptitude for incredibly detailed work, so that you can accurately review the scientific data in these massive documents. If you’re the kind of person who loves details, regulatory affairs may very well be for you. Since many people simply aren’t interested in this detail-oriented work, expressing your interest will go a long way towards helping you land a position in the department. Regulatory affairs is an industry that oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use.
Regulatory affairs professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development. In the drug, medical device, and biologic product industries, these phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. As always, there are several key considerations you should explore in order to determine if a career in regulatory affairs is right for you. Most importantly, you should evaluate both your personal and professional goals to better understand how a career in regulatory affairs can help you meet your goals. Strong writing and communication skills are required, as you’ll have to explain the reasoning behind your recommendations to busy senior management officials who may have only a few minutes of time for your advice. Formal education in science or medicine is necessary to understand the research and experimentation that goes into developing new pharmaceuticals, cosmetics, medical devices, or other products, and to ensure that research and development has proceeded according to regulatory requirements. The remainder are employed by a mix of academic institutions, clinical research organizations, government agencies, hospitals, and healthcare organizations. With so many options, regulatory professionals can choose to work in organizations of any size, ranging from 10 to 10,000 employees. Some regulatory affairs professionals manage clinical studies or develop marketing approval policies, while others design labels for food- and drug-related products. Many regulatory professionals carry titles such as regulatory affairs manager, food safety inspector, clinical research associate, or director of quality assurance. In the food industries, regulatory professionals engage with products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle.
They also review marketing, legal, and technical documentation, including case files and clinical research reports, to assess compliance with global regulatory agency policies, regulations, and standards. Regulatory affairs specialists may also recommend courses of remediation to help companies achieve the necessary levels of compliance. Acting as a liaison between manufacturing organizations and federal agencies, they may be responsible for submitting critical regulatory documents, with the goal of approval for sale and distribution.
Senior-level regulatory professionals often make strategic business decisions that have significant legal and financial repercussions. A large part of a regulatory affairs role, at all levels, is to interpret and communicate these implications to a diverse set of internal and external stakeholders. These regulatory professionals play a critical role in the development and distribution of medical technological advancements and disease-free food, improving people’s health and welfare around the world. But what do these professionals actually do on a daily basis?
Gaining a NanoDegree in Medical Device Regulatory Affairs is one way to gain this experience and help you translate knowledge into action. At BBMI, students in the regulatory affairs program have the opportunity to work alongside faculty on short-term, real-world projects at leading organizations. You’ll get to make a tangible difference by ensuring that the pharmaceuticals, medical devices, cosmetics, foods, and nutritional products that we all use are safe and effective. An alternative to research-based science careers, a career in regulatory affairs lets you stay at the forefront of science without the pressure and unpredictability of an academic or research and development career.