Faced with the daunting task of ensuring compliance with stringent regulations pertaining to the development and commercialization of medical device products, Regulatory Affairs groups rely on their own internal effectiveness and efficiencies to remain productive. Developing an understanding of the optimal resourcing and staffing levels will help Regulatory Affairs leaders in prioritizing roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this study to establish evidence-based benchmarks describing performance levels, approaches and boundaries - as well as to capture forward-looking insights about high-performance in the Regulatory Affairs function at medical device companies. In particular, the study identifies key performance indicators for regulatory budget, staffing, submissions trends, management factors, critical regulatory roles, responsibilities and off-shoring/outsourcing trends. Also, it highlights current and future trends shaping the Medical Device Regulatory Affairs function.