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Quality, Compliance and Regulatory » Regulatory Affairs
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Regulatory Affairs groups help guide their organizations through the regulatory labyrinth that companies must navigate as part of developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies to remain productive. Optimal resourcing and staffing help Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish metrics around Regulatory Affairs' budget and FTEs for medical device companies. In addition, this study gleans insights from regulatory leaders at device organizations regarding anticipated future resource trends in Regulatory Affairs.
This study presents spend, FTE and consultant benchmarks for the medical device industry. Specifically, the research includes spend, FTE and consultant ratios, such as regulatory spend per FTE, FTEs per $100M in revenue, and consultants per $100M in revenue. In addition, the study contains quantitative benchmarks and qualitative insights around anticipated Regulatory Affairs staffing trends in the medical device sector, including the use of outsourcing and offshoring.
Medical device regulatory leaders can use this study to compare their spend, FTE and consultant ratios and benchmarks with those of leading medical device companies.
Regulatory Affairs 2010 Staffing: Regulatory Affairs staffing averages 2.3 FTEs per $100M in medical device revenue. Headcount has remained the same for half of the benchmark class during the past three years as pressures to cut costs are mounting.
Outsourcing Levels: Regulatory leaders don’t expect outsourcing levels to grow in the next three years – in fact a third believe they will shrink.
For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eight regulatory leaders representing eight leading medical device organizations. In addition, executive interviews were conducted with selected participants to produce qualitative insights.
Consumer Products; Medical Device; Chemical; Technology; Health Care; Pharmaceutical; Orthopaedics
Bausch & Lomb; Edwards Lifesciences; BD; Roche Diagnostics; Boston Scientific; Ethicon; Johnson & Johnson; Medtronic; Zimmer