ABSTRACT
Historically, the role of the regulatory affairs function within companies that develop and sell medical devices has been more tactical than strategic. Regulatory reforms as well as the increased availability of real-world safety and efficacy data continue to alter the path to approval and the underlying investment case for medical devices. The regulatory environment in the global medical device industry is and will continue to undergo major shifts. The regulatory environment is changing rapidly and professionals must be able to gauge how new developments will affect the future environment. Historically, the regulatory professional has served an important operational role within a life sciences organization. The primary skill sets necessary for the completion of the tasks are excellent organizational and managerial skills as well as a thorough understanding of standards and regulations.
